FDA Adverse Event
Injury
Summary report: N
UNK DEPUY MENISCAL BEARINGS
MDR report key: 1171254
·
Received September 19, 2008
Report
- Report Number
- 1818910-2008-03764
- Event Type
- Injury
- Date Received
- September 19, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 21, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, GIVEN THE LENGTH OF TIME IMPLANTED, PRODUCT WEAR OUT WAS LIKELY A CONTRIBUTING FACTOR. THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT, POLY WEAR OF THE BEARINGS AND PATELLA POLY, AND OSTEOLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK DEPUY MENISCAL BEARINGS | TOTAL KNEE PROSTHESIS | JWH | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |