FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 56
MDR report key: 2840063
·
Received November 20, 2012
Report
- Report Number
- 1818910-2012-24765
- Event Type
- Injury
- Date Received
- November 20, 2012
- Report Date
- August 16, 2012
- 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
- TX, US
- Reporter Occupation
- ATTORNEY
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. (B)(4).
Description of Event or Problem · 1
LITIGATION ALLEGES THAT THE PATIENT SUFFERED SEVERE PAIN, DISABILITY, PHYSICAL IMPAIRMENT, DISFIGUREMENT, AGGRAVATION OF A PRE-EXISTING CONDITION AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR CUPS 56 | TOTAL HIP IMPLANT | KWA | DEPUY INTERNATIONAL | 2840498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |