FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY HEAD
MDR report key: 876436
·
Received July 3, 2007
Report
- Report Number
- 1818910-2007-02235
- Event Type
- Injury
- Date Received
- July 3, 2007
- Date of Event
- June 27, 2007
- Report Date
- June 27, 2007
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
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 CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.
Description of Event or Problem · 1
PATIENT REVISED BECAUSE OF PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY HEAD | TOTAL HIP REPLACEMENT | KWY | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA YR | Required Intervention |