FDA Adverse Event
Injury
Summary report: N
UNK DEPUY STEM
MDR report key: 886585
·
Received July 27, 2007
Report
- Report Number
- 1818910-2007-02351
- Event Type
- Injury
- Date Received
- July 27, 2007
- Date of Event
- July 4, 2007
- Report Date
- July 4, 2007
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND LOT CODE WAS UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OR PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.
Description of Event or Problem · 1
PATIENT REVISED BECAUSE OF SQUEAKING AND LACK OF WEIGHT BEARING, FOUND STEM FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK DEPUY STEM | TOTAL HIP REPLACEMENT | KWY | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |