FDA Adverse Event
Injury
Summary report: N
LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD
MDR report key: 4250970
·
Received November 14, 2014
Report
- Report Number
- 3010536692-2014-01662
- Event Type
- Injury
- Date Received
- November 14, 2014
- Date of Event
- October 17, 2014
- Report Date
- October 17, 2014
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2014-01660, 01661.
Additional Manufacturer Narrative · 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.
Description of Event or Problem · 1
ALLEGEDLY PER DX WAS REVISION DUE TO POSSIBLE FX DISLOCATION OF CUP LINER. LINER WAS DISLOCATED AND NOT IN THE CUP. THERE WAS LARGE AMOUNTS OF BLACK TISSUE, PRESUMABLY FROM METAL-ON-HEAD WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738350 | LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD | HIP COMPONENT | LPH | MICROPORT ORTHOPEDICS INC. | 2600-00XX | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |