FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY HEAD
MDR report key: 1020979
·
Received March 26, 2008
Report
- Report Number
- 1818910-2008-00951
- Event Type
- Injury
- Date Received
- March 26, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 10, 2008
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND LOT CODES WERE UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS DISLOCATION (RIGHT SIDE). POLY WEAR WAS FOUND INTRAOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY HEAD | TOTAL HIP REPLACEMENT | KWB | DEPUY INTERNATIONAL, LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |