FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2111159
·
Received June 2, 2011
Report
- Report Number
- 3005477969-2011-00109
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- December 8, 2010
- Report Date
- July 15, 2011
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT HAS BEEN IDENTIFIED THAT NO BHR REVISION WAS PERFORMED ON THIS PATIENT AFTER ALL. THE DEVICES ARE FUNCTIONING WELL AND HAS NOT BEEN REVISED. CONFUSION HAS BEEN CAUSED DUE TO INCOMPETENCE. THIS EVENT DOES NOT MEET THE CRITERIA OF A COMPLAINT.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R | FEMORAL HEAD, PART# 74121150, LOT# UNKNOWN |