FDA Adverse Event
Injury
Summary report: N
POLISH FINNED TIBIAL TRAY 75MM
MDR report key: 6446000
·
Received March 30, 2017
Report
- Report Number
- 0009610576-2017-00011
- Event Type
- Injury
- Date Received
- March 30, 2017
- Report Date
- March 30, 2017
- Manufacturer
- BIOMET SPAIN, S.L.
- Product Code
- KRO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SIMILAR TO WARSAW OSS/FINNED TIBIAL TRAY (K945028)--(B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A KNEE REVISION DUE TO PATIENT ALLEGATIONS OF LOOSENING AND METALLOSIS. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENTS NOTICE AND THE ALLEGATIONS THERE IN ARE UNVERIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228697 | POLISH FINNED TIBIAL TRAY 75MM | PROSTHESIS, KNEE | KRO | BIOMET SPAIN, S.L. | 2008040227 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |