FDA Adverse Event
Malfunction
Summary report: N
TOTAL ASR FEM IMP SIZE 49
MDR report key: 2023417
·
Received March 2, 2011
Report
- Report Number
- 1818910-2011-02726
- Event Type
- Malfunction
- Date Received
- March 2, 2011
- Report Date
- February 1, 2011
- 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).
Additional Manufacturer Narrative · 1
THIS MEDWATCH IS BEING REJECTED AS IT IS A DUPLICATE OF 1818910-2011-20313.
Description of Event or Problem · 1
THE PATIENT HAS BEEN RECOMMENDED FOR AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL ASR FEM IMP SIZE 49 | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | 1948620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |