FDA Adverse Event
Injury
Summary report: N
PFC SIG MOD TIB TRAY CEM SZ2.5
MDR report key: 2034052
·
Received March 24, 2011
Report
- Report Number
- 1818910-2011-04846
- Event Type
- Injury
- Date Received
- March 24, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- PMA / PMN Number
- K884796
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADD'L REPORTS AGAINST THE LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT W/O THE PRODUCT TO EXAMINE. 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 THE PRODUCT AND/OR ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS POLYWEAR, OSTEOLYSIS, AND LOOSE TIBIA AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIG MOD TIB TRAY CEM SZ2.5 | 87JWH | JWH | DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. | NA | 284248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |