FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3171775
·
Received June 17, 2013
Report
- Report Number
- 3005477969-2013-00240
- Event Type
- Injury
- Date Received
- June 17, 2013
- Date of Event
- February 26, 2011
- Report Date
- August 8, 2013
- 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
ADDITIONAL INFORMATION:UPON RECEIPT OF NEW INFORMATION, IT HAS BEEN IDENTIFIED THAT THIS EVENT WAS REPORTED TWICE THROUGH DIFFERENT SOURCES, AND AS SUCH, THIS MDR (REF. 3005477969-2013-00240) IS A DUPLICATION OF A PREVIOUSLY REPORTED MDR (MDR REF. 3005477969-2012-00032).
Additional Manufacturer Narrative · 1
THE USE OF A COMPETITOR'S FEMORAL STEM IN CONJUNCTION WITH THE DEVICES CONCERNED CONSTITUES AN OFF LABEL APPLICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HIP DEVICES WERE REVISED DUE TO ASEPTIC LOOSENING OF THE SOCKET AND ASEPTIC LOOSENING OF THE FEMORAL STEM.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED IN (B)(6) 2011 DUE TO AN ADVERSE REACTION TO METAL DEBRIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272774 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS, LTD. | 50485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R | ZIMMER CPT STEM, PART AND LOT # UNKNOWN| FEMORAL HEAD, PART AND LOT # UNKNOWN |