FDA Adverse Event
Injury
Summary report: N
PFC SIGMA STAB INS SZ3 8MM
MDR report key: 1040466
·
Received May 8, 2008
Report
- Report Number
- 1818910-2008-01763
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- April 22, 2008
- Report Date
- April 22, 2008
- Manufacturer
- DEPUY - RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC
- Product Code
- JWH
- PMA / PMN Number
- K961685
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PROD WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MFG LOT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLYETHYLENE WEAR. NO EVIDENCE WAS FOUND SUGGESTING PROD ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
THE PT WAS REVISED BECAUSE OF WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMA STAB INS SZ3 8MM | 87JWH | JWH | DEPUY - RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC | NA | 46245A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |