FDA Adverse Event
Injury
Summary report: N
UNKNOWN HIP HEAD
MDR report key: 2151253
·
Received June 30, 2011
Report
- Report Number
- 1818910-2011-12101
- Event Type
- Injury
- Date Received
- June 30, 2011
- Report Date
- May 31, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
REASON FOR REVISION: PERIPROSTHETIC FRACTURE AND INFECTION. THERE WERE A NUMBER OF DIFFERENT CAUSES FOR REVISION, HOWEVER, THEY CONCLUDE AT THE END THAT THE FAILURES WERE DUE TO NECROSIS OF PERI-IMPLANT BONE AND SOFT TISSUE FROM MASSIVE METALLOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN HIP HEAD | TOTAL HIP PROSTHESIS | KWY | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |