FDA Adverse Event
Injury
Summary report: N
TOTAL HIP BALL 28MM +3
MDR report key: 1962463
·
Received January 7, 2011
Report
- Report Number
- 1818910-2011-00266
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 10, 2010
- Report Date
- December 10, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDI
- PMA / PMN Number
- K860701
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
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
THE PT WAS REVISED DUE TO DISLOCATION AND FOUND POLY WEAR ON THE INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL HIP BALL 28MM +3 | 87JDI | JDI | DEPUY ORTHOPAEDICS, INC. | NA | S5LCB1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization |