FDA Adverse Event
Injury
Summary report: N
DEPUY HIP IMPLANT
MDR report key: 8102062
·
Received November 23, 2018
Report
- Report Number
- MW5081597
- Event Type
- Injury
- Date Received
- November 23, 2018
- Date of Event
- October 22, 2018
- Report Date
- November 21, 2018
- Manufacturer
- DEPUY SYNTHES, INC.
- Product Code
- KWA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
THIS IS AN ONGOING PROBLEM CAUSED BY COBALT/CHROMIUM DEPUY HIP IMPLANT. IT DID NOT START ON A SPECIFIC DATE. METAL ON METAL HIP REPLACEMENT. I AM AN ACTIVE PERSON WALKING AND BIKE RIDING A COUPLE THOUSAND MILES PER YEAR, SO THERE IS A LOT OF METAL DEBRIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 938655 | DEPUY HIP IMPLANT | PROSTHESIS, HIP, SEMI-CONSTRAINED, (METAL UNCEMENTED ACETABULAR COMPONENT) | KWA | DEPUY SYNTHES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| O| S |