FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 56
MDR report key: 3012673
·
Received March 20, 2013
Report
- Report Number
- 1818910-2013-03434
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- March 11, 2013
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.
Additional Manufacturer Narrative · 1
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Description of Event or Problem · 1
LITIGATION ALLEGES PATIENT HAD PAIN, DISCOMFORT, SORENESS, SWELLING, SHEDDING OF METAL DEBRIS INTO THE BLOODSTREAM, TISSUE DAMAGE, AND DECREASED MOBILITY, LOSS OF MUSCLE MASS AND DETERIORATION OF SOFT TISSUE AFTER ASR HIP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116681 | ASR ACETABULAR CUPS 56 | TOTAL HIP REPLACEMENT | KWA | DEPUY INTERNATIONAL | 2382358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |