FDA Adverse Event
Injury
Summary report: N
PFC SIGMARP STB TB IN 4 10.0
MDR report key: 1153049
·
Received September 5, 2008
Report
- Report Number
- 1818910-2008-03874
- Event Type
- Injury
- Date Received
- September 5, 2008
- Date of Event
- August 8, 2008
- Report Date
- August 8, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, DEPUY CORK
- Product Code
- NJL
- PMA / PMN Number
- P830055/S074
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 MANUFACTURING 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 INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
THE PATIENT WAS REVISED BECAUSE OF INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMARP STB TB IN 4 10.0 | 87 NJL | NJL | DEPUY ORTHOPAEDICS, DEPUY CORK | NA | 2572835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |