FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 56
MDR report key: 3032710
·
Received April 3, 2013
Report
- Report Number
- 1818910-2013-06421
- Event Type
- Injury
- Date Received
- April 3, 2013
- Date of Event
- April 3, 2018
- Report Date
- March 26, 2013
- Manufacturer
- DEPUY INTERNATIONAL LTD. 8010379
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
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. NOT RETURNED.
Additional Manufacturer Narrative · 1
PRODUCT COMPLAINT # (B)(4).
Description of Event or Problem · 1
PATIENT IS SEEKING LEGAL ACTION.
Description of Event or Problem · 1
ASR LITIGATION ALLEGED PAIN, WEAKNESS, DIFFICULTY WITH SIMPLE DAILY LIVING ACTIVITIES, HIGH METAL IONS, INJURY, SUFFERING AND EMOTIONAL DISTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136676 | ASR ACETABULAR CUPS 56 | ACETABULAR CUP | KWA | DEPUY INTERNATIONAL LTD. 8010379 | 1831565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Other| R | ADAPTER SLEEVES 12/14 +8| ASR UNI FEMORAL IMPL SIZE 49| CORAIL2 LAT COXA VARA SIZE 13 |