FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY ASR HIP
MDR report key: 2011329
·
Received March 4, 2011
Report
- Report Number
- 1818910-2011-03465
- Event Type
- Injury
- Date Received
- March 4, 2011
- Date of Event
- November 24, 2014
- Report Date
- February 19, 2015
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- KWA
- PMA / PMN Number
- PK040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- N
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.
Description of Event or Problem · 1
LITIGATION PAPERS ALLEGE, THE PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, EXHIBITED SYMPTOMS OF A LOOSE IMPLANT AND HAS SUFFERED A LOSS OF MUSCLE MASS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEPUY ASR HIP | 87KWA | KWA | DEPUY INTERNATIONAL, LTD. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |