FDA Adverse Event
Injury
Summary report: N
PFC SIGMA TC3 FEM RT SZ3
MDR report key: 1833745
·
Received September 8, 2010
Report
- Report Number
- 1818910-2010-06503
- Event Type
- Injury
- Date Received
- September 8, 2010
- Date of Event
- August 25, 2010
- Report Date
- August 25, 2010
- Manufacturer
- DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- PMA / PMN Number
- K952830
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT 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 TO ADDRESS INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMA TC3 FEM RT SZ3 | 87JWH | JWH | DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. | NA | ED5D94 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |