MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-09-11 for SYNPLUG CEMENT RESTRICTOR manufactured by Isotis Orthobiologics, Inc.
[119929326]
No product samples, cts, lateral radiographs, initial or serial radiographs or other medical records have been provided. Alleged osteolysis at the proximal end of the prosthetic shaft. There is osteolytic resorptive changes at the distal tip of the femoral prosthesis. A medical advisor review of the reporting surgeons notes, cement did not extend beyond the tip of the prosthesis, cortical thinning at the distal tip is likely insignificant without further imaging to confirm. Within in medical probability, at 15 years, the synplug did not cause or contribute to the proximal loosening.
Patient Sequence No: 1, Text Type: N, H10
[119929327]
Initial hip replacement (hip arthroplasty) surgery involving a hip prosthesis, thp cement, and synplug cement restrictor, left side occurred in 2003. Ct scan was reportedly performed and allegedly a fine lysis margin with pathologically metabolism formed at the proximal portion of the cemented femoral shaft with signs of loosening. The surgeon additionally noted osteolysis in the left distal tip of the prosthetic shaft. Ct scans were not provided. No plans for revision. Surgeon will monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2090010-2018-00004 |
| MDR Report Key | 7866681 |
| Report Source | FOREIGN |
| Date Received | 2018-09-11 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-08-08 |
| Date Mfgr Received | 2018-08-23 |
| Date Added to Maude | 2018-09-11 |
| 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 | MR. AARON |
| Manufacturer Street | 5770 ARMADA DRIVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNPLUG CEMENT RESTRICTOR |
| Generic Name | CEMENT OBTURATOR |
| Product Code | LZN |
| Date Received | 2018-09-11 |
| 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 | IRVINE CA 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-11 |