FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN DEPUY ASR SZ. 56 CUP
MDR report key: 2770906
·
Received October 3, 2012
Report
- Report Number
- 1818910-2012-22606
- Event Type
- Malfunction
- Date Received
- October 3, 2012
- Date of Event
- September 12, 2012
- Report Date
- September 18, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
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
PATIENT WAS REVISED TO ADDRESS STEM LOOSENING AND PAIN. DOI: (B)(6) 2008 - DOR: (B)(6) 2012 (RIGHT SIDE). (B)(4) 2012 - PATIENT'S OPERATIVE NOTES RECEIVED. IT WAS NOTED THAT THE SPECIMEN CAME BACK POSITIVE FOR ACUTE INFLAMMATION AND ELEVATED COBALT LEVELS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR SZ. 56 CUP | ACETABULAR CUP | KWA | DEPUY INTERNATIONAL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Required Intervention |