FDA Adverse Event
Injury
Summary report: N
BHR ACETABULAR CUP 56MM
MDR report key: 2021910
·
Received March 17, 2011
Report
- Report Number
- 3005477969-2011-00066
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- September 1, 2010
- Report Date
- March 17, 2011
- 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
FIRST REVISION FOR THIS SAME PATIENT REPORTED IN MDR # 3005477969-2011-00062.
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BHR ACETABULAR CUP 56MM | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 077524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |