FDA Adverse Event
Injury
Summary report: N
PFC SIGMA C/R POR FE LF SZ 2.5
MDR report key: 1250785
·
Received December 2, 2008
Report
- Report Number
- 1818910-2008-05750
- Event Type
- Injury
- Date Received
- December 2, 2008
- Date of Event
- November 4, 2008
- Report Date
- November 4, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- PMA / PMN Number
- K943462
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL WAS NOT POSSIBLE, AS THE PROD WAS NOT RETURNED. PROD INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT REPORTED DEVICE LOOSENING. BASED ON THE INVESTIGATION FINDINGS, 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 REC'D, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT REVISED TO ADDRESS LOOSE FEMORAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMA C/R POR FE LF SZ 2.5 | 87JWH | JWH | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |