FDA Adverse Event
Injury
Summary report: N
ASR ACETABULAR CUPS 56
MDR report key: 2863246
·
Received December 10, 2012
Report
- Report Number
- 1818910-2012-29104
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- November 20, 2012
- Report Date
- April 11, 2013
- 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
- MA, US
- Reporter Occupation
- PHYSICIAN
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.
Additional Manufacturer Narrative · 1
THIS IS A DUPLICATE REPORT OF 1818910-2012-08209. THIS REPORT, 1818910-2012-29104, WILL BE REJECTED; 1818910-2012-08209 WILL BE KEPT FOR INVESTIGATION PURPOSES.
Description of Event or Problem · 1
PATIENT WAS REVISED DUE TO ABNORMAL MRI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASR ACETABULAR CUPS 56 | ACETABULAR CUP | KWA | DEPUY INTERNATIONAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |