FDA Adverse Event
Injury
Summary report: N
BHR
MDR report key: 4091210
·
Received September 16, 2014
Report
- Report Number
- 3005477969-2014-00497
- Event Type
- Injury
- Date Received
- September 16, 2014
- Date of Event
- February 8, 2013
- Report Date
- November 27, 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 IN (B)(6) 2013. THE DEVICES WERE IMPLANTED IN (B)(6) 2012. PAIN AFTER PATIENT STUBBED HIS TOE AND A PULLING SENSATION IN GROIN REPORTED. ELEVATED METAL ION LEVELS AND FEMORAL COMPONENT LOOSENING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573401 | BHR | ACETABULAR CUP | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 10MW31221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| R | HEMI HEAD, # 74122546, LOT # 08JW18839| FEMORAL HEAD, # 74121146, LOT # UNKNOWN| FEMORAL HEAD, PART AND LOT # UNKNOWN| FEMORAL STEM, # 71357003, LOT # 10FM00299A| MODULAR SLEEVE, # 74222200, LOT # 09HW24558| FEMORAL STEM, # 71356004, LOT # UNKNOWN |