FDA Adverse Event
Injury
Summary report: N
PFC SIGMARP STB TB IN 2.5 15.0
MDR report key: 1972326
·
Received January 25, 2011
Report
- Report Number
- 1818910-2011-01119
- Event Type
- Injury
- Date Received
- January 25, 2011
- Date of Event
- December 29, 2010
- Report Date
- December 29, 2010
- Manufacturer
- DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- NJL
- PMA / PMN Number
- P830055/S074
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS LOOSENING OF TIBIAL TRAY AT CEMENT/IMPLANT INTERFACE. COMPETITOR'S CEMENT WAS USED IN THE PRIMARY SURGERY. OSTEOLYSIS WAS ALSO REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMARP STB TB IN 2.5 15.0 | 87NJL | NJL | DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC. | NA | 59145A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |