FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR HEAD
MDR report key: 1983191
·
Received January 31, 2011
Report
- Report Number
- 1818910-2011-01453
- Event Type
- Injury
- Date Received
- January 31, 2011
- Date of Event
- January 6, 2011
- Report Date
- March 19, 2014
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- PK040627
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS PAIN. EXCESSIVE SOFT TISSUE DAMAGE WAS NOTED BY THE SURGEON. PROXIMAL FEMUR AND EXPOSED ACETABULAR RIM WAS WHITE AND SEEMED DEAD. OSTEOLYSIS WAS ALSO NOTED IN AREAS OF ACETABULUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR HEAD | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |