FDA Adverse Event
Injury
Summary report: N
R3
MDR report key: 3172574
·
Received June 17, 2013
Report
- Report Number
- 3005477969-2013-00250
- Event Type
- Injury
- Date Received
- June 17, 2013
- Date of Event
- September 18, 2012
- Report Date
- May 1, 2014
- 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
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. THE DEVICES WERE IMPLANTED IN (B)(6) 2008. DETERIORATING MOBILITY AND PAIN WHEN WALKING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274298 | R3 | COCR ACETABULAR LINER | NXT | SMITH & NEPHEW ORTHOPAEDICS LTD | 07MW15117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R | MODULAR SLEEVE, # 74222200, LOT # 08CW16018| ACETABULAR SHELL, # 71331956, LOT # 07MM06288A| SPHERICAL SCREW, # 71332515, LOT # 07KW13277| SPHERICAL SCREW, # 71332530, LOT # 07JM01738| HOLE COVER, # 71330001, LOT # 08EM07174| MODULAR HEAD, # 74222144, LOT # 08CW16175| FEMORAL STEM, # 71357004, LOT # 07FM11785A |