FDA Adverse Event
Injury
Summary report: N
BIOMET/SURGICAL SPECIALITES
MDR report key: 2061716
·
Received April 13, 2011
Report
- Report Number
- MW5020277
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 13, 2011
- Manufacturer
- BIOMET, INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
INFECTED RIGHT TOTAL HIP REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET/SURGICAL SPECIALITES | ORTHOPEDIC IMPLANTS | LPH | BIOMET, INC. | ARCOMXL 36MM RLC | 428680 | |
| 2 | BIOMET/SURGICAL SPECIALITES | ORTHOPEDIC IMPLANTS | LPH | BIOMET, INC. | 357600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization |