FDA Adverse Event
Injury
Summary report: N
VERSYS FEMORAL HEAD
MDR report key: 3760807
·
Received April 9, 2014
Report
- Report Number
- 2648920-2014-00079
- Event Type
- Injury
- Date Received
- April 9, 2014
- Date of Event
- February 19, 2014
- Report Date
- March 10, 2014
- Manufacturer
- ZIMMER
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN, INSTABILITY, AND FLUID AROUND JOINT. DURING REVISION, IT WAS DISCOVERED THAT THE POLYETHYLENE INNER RING WAS BROKEN OFF AND CORROSION WAS FOUND ON THE HEAD TRUNNION AND STEM. AN 8MM GROOVE THAT WAS WORN OUT WAS ALSO DISCOVERED ON THE MODULAR NECK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213255 | VERSYS FEMORAL HEAD | LPH | ZIMMER | 60816001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | LOT #60806888| CATALOG #00771301300, LOT #60819846| KINECTIV MODULAR NECK, CATALOG #00784801201,| TRILOGY ACETABULAR CROSSLINKED POLYETHYLENE LINER,| THE FOLLOWING PRODUCTS WERE MANUFACTURED BY| ZIMMER WARSAW, IN, USA| CATALOG #00630505840, LOT #61587111| ZIMMER M/L TAPER MODULAR FEMORAL STEM, |