FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR IMPLANT 50
MDR report key: 2141463
·
Received June 22, 2011
Report
- Report Number
- 1818910-2011-10805
- Event Type
- Injury
- Date Received
- June 22, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 24, 2011
- Manufacturer
- DEPUY INTL. LTD.
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
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).
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE PT WAS REVISED TO ADDRESS ALVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR IMPLANT 50 | 87KWA | KWA | DEPUY INTL. LTD. | NA | 2621508 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |