FDA Adverse Event
Malfunction
Summary report: N
ASR
MDR report key: 1953691
·
Received December 23, 2010
Report
- Report Number
- 1953691
- Event Type
- Malfunction
- Date Received
- December 23, 2010
- Date of Event
- December 16, 2010
- Report Date
- December 23, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
PATIENT IS MIDDLE-AGED WITH BILATERAL DEPUY ASR HIPS, WHICH ARE UNDER RECALL. HE HAS HAD DIFFICULTY WITH BOTH HIPS. HE HAS RESIDUAL PAIN IN THE GROIN AS WELL AS SNAPPING AND CLICKING SENSATIONS IN BOTH HIPS. UPON EXAMINATION, IT APPEARS HE HAS A COMPONENT OF ILIOPSOAS TENDON IMPINGEMENT ANTERIORLY AS WELL AS POTENTIAL ISSUES WITH THE HIP. HIS HIP WAS ASPIRATED TO RULE OUT INFECTION, AND HE UNDERWENT A CT SCAN TO VISUALIZE ANY COMPONENT MALPOSITION. IT WAS FELT FROM A TECHNICAL STANDPOINT THE PATIENT'S HIPS WERE WELL IMPLANTED, HOWEVER THE PT CONTINUED TO HAVE PROGRESSIVE PAIN. WITH KNOWLEDGE OF THE RECALL, THE PATIENT WISHED TO PROCEED WITH REVISION ARTHROPLASTY TO NON-METALLIC BEARING SURFACES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR | PROSTHESIS, HIP, SEMI-CONSTRAINED | KWA | DEPUY ORTHOPAEDICS, INC. | * | 2840498-3009704-2901761-D498K1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | NO OTHER THERAPIES |