FDA Adverse Event
Injury
Summary report: N
TOTAL ASR FEM IMP SIZE 45
MDR report key: 2162218
·
Received July 7, 2011
Report
- Report Number
- 1818910-2011-12131
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 7, 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).
Description of Event or Problem · 1
THE PT WAS REVISED TO ADDRESS PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL ASR FEM IMP SIZE 45 | 87KWA | KWA | DEPUY INTL., LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |