MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-11-20 for SYNPLUG - UNKNOWN SIZE XXX-SYNPLUG manufactured by Isotis Orthobiologics, Inc.
[31785041]
To date, there are no conclusive findings from this or similar complaint investigations, or from technical or clinical information in the literature that proves or disproves a causal relationship between synplug? & optiplug? Biodegradable cement restrictors or the materials they are manufactured with, and periprosthetic osteolysis (or fractures as a result). There are also no data or findings that would suggest that only some subset of all the products manufactured might be affected. The finding of osteolysis surrounding the distal cement restrictor is unexpected, and undesirable; however, periprosthetic osteolysis in total hip arthroplasty is a well-known problem that is typically a multifactorial process and may be identified through routine radiographic follow-up.
Patient Sequence No: 1, Text Type: N, H10
[31785042]
It was reported the patient's osteolysis was identified by x-ray bilaterally, 10 years following bilateral hip repair/transplant. The patient underwent a double-sided hip transplant for coxarthrosis on (b)(6) 2005. It was reported, "the patient was seen for a planned clinical/radiological follow-up 10 years after the above mentioned operation took place. The patient is very pleased with the results of the operation. She described no complaints in her current everyday life. Years ago, she described to have pain in the area of the left m. Iliopsoas, which had regressed independently in the course. X-ray results show no signs of implant loosening. Emergent 58mm measured osteolysis in the region of the lesser trochanter on the right side, also newly occurring minor osteolysis in the ap image measuring 23mm in the area of the distal shaft third left. (23mm measured in the ap image). The patient has been satisfied with the results for 10-years. In question are osteolytic changes in the field of prosthetic sockets right and left. These are not very pronounced, but worth of observation. Special precautions are not necessary. We are planning a radiological follow-up in one year. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2015-00046 |
| MDR Report Key | 5240158 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-11-20 |
| Date of Report | 2015-10-28 |
| Date Mfgr Received | 2015-10-28 |
| Date Added to Maude | 2015-11-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Street | 2 GOODYEAR PLACE, SUITE A |
| Manufacturer City | IRVINE CA 96218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 96218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNPLUG - UNKNOWN SIZE |
| Generic Name | SYNPLUG |
| Product Code | LZN |
| Date Received | 2015-11-20 |
| Catalog Number | XXX-SYNPLUG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | 2 GOODYEAR PLACE, SUITE A 2 GOODYEAR PLACE, SUITE A IRVINE CA 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2015-11-20 |