FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2200632
·
Received August 11, 2011
Report
- Report Number
- 3005477969-2011-00174
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- August 9, 2011
- Report Date
- October 13, 2011
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SMITH & NEPHEW HAVE RECEIVED DUPLICATE REPORTS RELATED TO THIS EVENT AND INADVERTENTLY SUBMITTED TWO MDRS FOR THE SAME CASE (3005477969-2011-00173 + 3005477969-2011-00174). PLEASE TREAT THIS REPORT AS THE MASTER CASE EVALUATION AND 3005477969-2011-00173 AS AN ERRONEOUS DUPLICATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ACETABULAR CUP HAD CHANGED ORIENTATION WITHIN 6 WEEKS OF IMPLANTATION. FEMORAL HEAD REMAINED IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED 6 WEEKS POST-IMPLANTATION DUE TO THE HORIZONTAL POSITION OF THE CUP AND REPORTED PATIENT PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 11CW32011 006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Hospitalization| R | FEMORAL HEAD, PART# 74121150, LOT# UNKNOWN |