FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 50
MDR report key: 2537094
·
Received April 16, 2012
Report
- Report Number
- 1818910-2012-09550
- Event Type
- Injury
- Date Received
- April 16, 2012
- Report Date
- February 17, 2012
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VI, 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. (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.
Additional Manufacturer Narrative · 1
ADDED: BRAND NAME, COMMON DEVICE NAME, CATALOG #/LOT #, PMA/510(K) #, IF FOLLOW-UP, WHAT TYPE, BIRTH DATE, MANUFACTURE DATE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.
Description of Event or Problem · 1
LITIGATION PAPERS ALLEGE PAIN AND LACK OF MOBILITY, AND METAL POISONING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR CUPS 50 | TOTAL HIP PROSTHESIS | KWA | DEPUY INTERNATIONAL | 2262955 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |