FDA Adverse Event
Injury
Summary report: N
VERSYS FEMORAL HEAD
MDR report key: 4142800
·
Received September 23, 2014
Report
- Report Number
- 2648920-2014-00246
- Event Type
- Injury
- Date Received
- September 23, 2014
- Date of Event
- August 28, 2014
- Report Date
- May 12, 2014
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WAS PREVIOUSLY SUBMITTED UNDER (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO ELEVATED COBALT LEVELS. DURING THE REVISION, METALLOSIS WAS NOTED ON THE NECK TRUNION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591096 | VERSYS FEMORAL HEAD | Prosthesis, hip, semi-constrained, metal/polymer, cemented | JDI | ZIMMER MANUFACTURING B.V. | 61138117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention | UNKNOWN ZMR FEMORAL BODY, CATALOG #UNK, LOT #UNK| UNKNOWN ZMR FEMORAL BODY, CATALOG #UNK, LOT #UNK |