FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 2192632
·
Received August 5, 2011
Report
- Report Number
- 3005477969-2011-00170
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- January 5, 2009
- Report Date
- September 27, 2018
- Manufacturer
- SMITH & NEPHEW ORTHOPAEDICS, LTD.
- Product Code
- NXT
- PMA / PMN Number
- P040033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CODES PROVIDED IN MDR 3005477969-2011-00170 FOLLOW UP #001 WERE ERRONEOUS. NO DEVICES HAVE BEEN RETURNED TO MANUFACTURER'S ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT HIP REVISION DUE TO LEG LENGTH DISCREPANCY AND PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR | RESURFACING FEMORAL HEAD | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R | 4120154/ACETLR CUP HAP 54MM W/ IMPTR/65937| 74121146/RESURFACING FEMORAL HEAD46MM/077678| ACETABULAR CUP, PART AND LOT UNKNOWN| ACETABULAR CUP, PART AND LOT UNKNOWN |