FDA Adverse Event
Injury
Summary report: N
UNK DEPUY HEAD
MDR report key: 1251303
·
Received December 3, 2008
Report
- Report Number
- 1818910-2008-05948
- Event Type
- Injury
- Date Received
- December 3, 2008
- Date of Event
- November 19, 2008
- Report Date
- November 19, 2008
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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 FOR THE KNOWN PRODUCT/LOTS DID NOT REVEAL ANY RELATED MFG DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR/CONTRIBUTION REGARDING THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.
Description of Event or Problem · 1
PT REVISED TO ADDRESS PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK DEPUY HEAD | TOTAL HIP REPLACEMENT | KWY | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |