FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR ACETABULAR CUP
MDR report key: 2893530
·
Received January 2, 2013
Report
- Report Number
- 1818910-2013-00255
- Event Type
- Injury
- Date Received
- January 2, 2013
- Date of Event
- June 22, 2012
- Report Date
- August 28, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- Removal / Correction Number
- Z1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
DUPLICATE OF MFR#: 1818910-2012-16092.
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 PAIN, DISCOMFORT AND PERMANENT INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 575 | UNKNOWN DEPUY ASR ACETABULAR CUP | TOTAL HIP IMPLANT | KWA | DEPUY INTERNATIONAL | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |