FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 1930957
·
Received December 17, 2010
Report
- Report Number
- 3005477969-2010-00230
- Event Type
- Injury
- Date Received
- December 17, 2010
- Date of Event
- November 18, 2010
- Report Date
- March 4, 2011
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A MALPOSITIONED ACETABULAR CUP AND PAIN. THE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 2 YEARS AFTER INSERTION. REVISION SURGERY TIME WAS REPORTEDLY EXTENDED BY APPROXIMATELY 31-60 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 83434 021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| R | FEMORAL HEAD, PART#74121150, LOT#12020 021 |