FDA Adverse Event
Injury
Summary report: N
FINN 71MMX14.4X115MM TIB BASE
MDR report key: 2883848
·
Received December 21, 2012
Report
- Report Number
- 0001825034-2012-02621
- Event Type
- Injury
- Date Received
- December 21, 2012
- Report Date
- November 30, 2012
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- KRO
- PMA / PMN Number
- PK945028
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. DATE EXPLANTED - UNKNOWN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02620 / 02621).
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT CUSTOM KNEE ARTHROPLASTY (B)(6) 1995. AN ALLEGED REVISION IS NEEDED DUE TO ALLEGED OSTEOLYSIS OF THE TIBIA. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FINN 71MMX14.4X115MM TIB BASE | PROSTHESIS, KNEE | KRO | BIOMET ORTHOPEDICS | N/A | 833470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |