FDA Adverse Event
Injury
Summary report: N
LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD
MDR report key: 2092015
·
Received May 18, 2011
Report
- Report Number
- 1043534-2011-00014
- Event Type
- Injury
- Date Received
- May 18, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 22, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDL
- PMA / PMN Number
- K004043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. (B)(4)
Additional Manufacturer Narrative · 1
CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. EVIDENCE PRODUCT WAS IN SPEC WHEN USED.
Description of Event or Problem · 1
ALLEGEDLY THE COMPONENT CAME OFF THE TRUNION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAGE(R) TRANSCEND(R) SUPERFINISHED FEMORAL HEAD | HIP COMPONENT | JDL | WRIGHT MEDICAL TECHNOLOGY, INC. | 077455265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R |