FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY INSERT
MDR report key: 1307884
·
Received February 5, 2009
Report
- Report Number
- 1818910-2009-00587
- Event Type
- Injury
- Date Received
- February 5, 2009
- Date of Event
- January 26, 2009
- Report Date
- January 26, 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
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFORMATION REQUIRED TO SEARCH THE COMPLAINT DATABASE WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLYETHYLENE WEAR. 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
PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA AND FEMORAL. POLY WEAR AND OSTEOLYSIS WERE DISCOVERED INTRAOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY INSERT | TOTAL KNEE REPLACEMENT | HSH | DEPUY ORTHOPAEDICS, INC. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |