FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY TIBIAL INSERT
MDR report key: 1062461
·
Received June 17, 2008
Report
- Report Number
- 1818910-2008-02126
- Event Type
- Injury
- Date Received
- June 17, 2008
- Date of Event
- May 20, 2008
- Report Date
- May 20, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC. - DEPUY RAYNHAM DIVISION
- Product Code
- HSH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED, AS THE PRODUCT CODE AND LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WERE NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS FUNCTION LIMITS AND PAIN (LEFT SIDE). POLY WEAR AND OSTEOLYSIS WERE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY TIBIAL INSERT | TOTAL KNEE PROSTHESIS | HSH | DEPUY ORTHOPAEDICS, INC. - DEPUY RAYNHAM DIVISION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |