FDA Adverse Event
Injury
Summary report: N
PFC SIG RPF INS SZ 2.5 12.5MM
MDR report key: 1040469
·
Received May 8, 2008
Report
- Report Number
- 1818910-2008-01666
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- April 24, 2008
- Report Date
- April 24, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS INC., DEPUY-RAYNHAM
- Product Code
- NJL
- PMA / PMN Number
- P830055/S087
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS 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 INFECTION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED DUE TO POSSIBLE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIG RPF INS SZ 2.5 12.5MM | 87NJL | NJL | DEPUY ORTHOPAEDICS INC., DEPUY-RAYNHAM | NA | AE4LF4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |