FDA Adverse Event
Malfunction
Summary report: N
MZA MAGNUM PF CUP 50MM O.D. X 44MM I.D.
MDR report key: 1652404
·
Received April 1, 2010
Report
- Report Number
- MW5015431
- Event Type
- Malfunction
- Date Received
- April 1, 2010
- Date of Event
- February 8, 2010
- Report Date
- April 1, 2010
- Manufacturer
- BIOMET
- Product Code
- KWB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B) (6) 2008. SUBSEQUENTLY, THE PT REPORTED PAIN AND RADIOGRAPHS REVEALED ACETABULAR CUP SPIN-OUT. REVISION WAS PERFORMED ON (B) (6) 2010 TO REMOVE AND REPLACE COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MZA MAGNUM PF CUP 50MM O.D. X 44MM I.D. | MZA MAGNUM PF CUP 50MM O.D. X 44MM I.D. | KWB | BIOMET | US157850 | 274430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |