FDA Adverse Event
Injury
Summary report: N
CONSERVE A-CLASS BFH HEAD SHORT NECK 36MM
MDR report key: 10673315
·
Received October 13, 2020
Report
- Report Number
- 3010536692-2020-00657
- Event Type
- Injury
- Date Received
- October 13, 2020
- Report Date
- October 13, 2020
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- KWA
- UDI-DI
- M68438AM36041
- PMA / PMN Number
- K051348
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ALLEGEDLY, PATIENT WAS REVISED DUE TO METAL ON METAL COMPLICATIONS. IMPLANT WAS REMOVED. ADDITIONAL INFORMATION RECEIVED ON 09/23/2020 FROM (B)(6): ADDING PRODUCT INFORMATION AND UPDATING IMPLANT DATE. ADDITIONAL INFORMATION RECEIVED ON 09/25/2020 FROM (B)(6): CONFIRMATION OF THE PRODUCT NUMBER OF THE SHELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1135016 | CONSERVE A-CLASS BFH HEAD SHORT NECK 36MM | HIP COMPONENT | KWA | MICROPORT ORTHOPEDICS INC. | 38AM3604 | 057437831 | M68438AM36041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |