FDA Adverse Event
Injury
Summary report: N
PLUS
MDR report key: 1850508
·
Received October 1, 2010
Report
- Report Number
- 9613369-2010-00053
- Event Type
- Injury
- Date Received
- October 1, 2010
- Date of Event
- May 3, 2010
- Report Date
- October 1, 2010
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS AARAU SWITZERLAND
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION SURGERY WAS REPORTED DUE TO ASEPTIC LOOSENING. THE ORIGINAL COMPLAINT DID NOT CONTAIN INFORMATION IDENTIFYING THIS DEVICE AS SELLABLE IN THE USA, NEW INFORMATION WAS RECEIVED CONFIRMING THAT THE DEVICE IS CURRENTLY SOLD IN THE USA AND SHOULD BE REPORTED TO THE FDA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUS | SL-PLUS MIA STEM 1 NON-CEM | JDH | SMITH & NEPHEW ORTHOPAEDICS AARAU SWITZERLAND | 75001939 | B0701852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| R | (B)(4) CERAMIC BALL HEAD, LOT # B0708077 |