FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 3915068
·
Received July 7, 2014
Report
- Report Number
- 3005477969-2014-00381
- Event Type
- Injury
- Date Received
- July 7, 2014
- Date of Event
- December 18, 2013
- Report Date
- December 2, 2014
- 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
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS AND ELEVATED COBALT AND CHROMIUM LEVELS. IMPLANTATION WAS IN (B)(6) 2008. REVISION SURGERY WAS IN (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393862 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 78792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| R | MODULAR SLEEVE, # (B)(4), LOT 08EW16966| HEMI HEAD, PART #(B)(4) AND LOT #NI| FEMORAL STEM, # (B)(4), LOT # 08DM20102A| FEMORAL HEAD, PART AND LOT NUMBERS UNKNOWN| FEMORAL STEM, PART AND LOT NUMBERS UNKNOWN| HEMI HEAD, # (B)(4), LOT # 08GW18101 |