FDA Adverse Event
Injury
Summary report: N
SIG MOD TIB TRAY CEM COCR 2.5
MDR report key: 3001136
·
Received March 13, 2013
Report
- Report Number
- 1818910-2013-13675
- Event Type
- Injury
- Date Received
- March 13, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 13, 2013
- Manufacturer
- 9616671 DEPUY (IRELAND)
- Product Code
- JWH
- PMA / PMN Number
- PK032151
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INITIAL REPORTING STATED PATIENT X-RAYS WERE NOT AVAILABLE FOR REVIEW. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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
CLINICAL REPORTS STATES REVISION DUE TO TIBIAL ASEPTIC LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105882 | SIG MOD TIB TRAY CEM COCR 2.5 | TIBIAL | JWH | 9616671 DEPUY (IRELAND) | 3238881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |