FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY TIBIAL TRAY
MDR report key: 1327226
·
Received February 23, 2009
Report
- Report Number
- 1818910-2009-00871
- Event Type
- Injury
- Date Received
- February 23, 2009
- Date of Event
- February 9, 2009
- Report Date
- February 9, 2009
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- HSH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS HE PRODUCTS WERE NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE LOOSENING AND PATELLAR CLUNK BASED ON THE PROVIDED INFO. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS PATELLAR CLUNK. THE FEMORAL, TIBIAL, AND PATELLAR COMPONENTS WERE FOUND TO BE LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY TIBIAL TRAY | TOTAL KNEE PROSTHESIS | HSH | DEPUY ORTHOPAEDICS, INC. | NA | NK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |