MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-08-08 for ELEVATED RIM LINER N/A 00885201236 manufactured by Zimmer, Inc..
[82666022]
(b)(4). The devices have not been returned for evaluation at this time and are being followed up on for return. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[82666023]
It was reported the acetabular liner would not lock into an acetabular cup during surgery. A significant delay to surgery was not reported. No further information has been made available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-05468 |
| MDR Report Key | 6776140 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-08-08 |
| Date of Report | 2018-05-10 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2016-10-20 |
| Date Added to Maude | 2017-08-08 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEVATED RIM LINER |
| Generic Name | PROSTHESIS, HIP |
| Product Code | OQI |
| Date Received | 2017-08-08 |
| Returned To Mfg | 2017-08-22 |
| Model Number | N/A |
| Catalog Number | 00885201236 |
| Lot Number | 63486480 |
| ID Number | (01) 0088902415589 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-08 |