FDA Adverse Event
Injury
Summary report: N
DEPUY ASR XL FEM IMP SIZE 45
MDR report key: 2071436
·
Received April 13, 2011
Report
- Report Number
- 1818910-2011-04251
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 14, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
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.
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).
Description of Event or Problem · 1
UPDATE: THE PATIENT WAS REVISED TO ADDRESS PAIN. PART AND LOT INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEPUY ASR XL FEM IMP SIZE 45 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 2773614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | ASR ACETABULAR IMPLANT 50| ASR TAP SLV ADAP 12/14 -1| CORAIL2 NON COL HO SIZE 10 |