FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY TIBIAL INSERT
MDR report key: 1213937
·
Received October 27, 2008
Report
- Report Number
- 1818910-2008-04699
- Event Type
- Injury
- Date Received
- October 27, 2008
- Date of Event
- October 3, 2008
- Report Date
- October 3, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- HSH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT REPORTED POLYETHYLENE WEAR; HOWEVER, POLYETHYLENE WEAR AFTER 15-YEARS IMPLANTATION SHOULD NOT BE UNEXPECTED. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS AND WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY TIBIAL INSERT | TOTAL KNEE PROSTHESIS | HSH | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |