BMT 360 TIB 5.0 OFFSET ADAPTER
Received Dec 2, 2019 · Event occurred Apr 5, 2018
Report 0001825034-2019-05419 · MDR key 9397766
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
185211
Lot number
497570
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
Not reported
- Pain
- Limited Mobility Of The Implanted Joint
- Pain
- Limited Mobility Of The Implanted Joint
Narrative
Description of Event or Problem
NO ADDITIONAL INFORMATION REPORTED.
Additional Manufacturer Narrative
UPON REASSESSMENT THE OFFSET ADAPTERS ARE NOT MEANT TO PROVIDE FIXATION THEREFORE THIS DEVICE IS NO LONGER CONSIDERED AS CAUSING/ CONTRIBUTING TO THE REPORTED EVENT. EVENT IS BEING REPORTED ON 0001825034-2019-05415, 0001825034-2019-05416, 0001825034-2019-05417, 0001825034-2019-05418. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD SSK 360 LEFT FEMUR CATALOG 185288 LOT 2823216, VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 115580, VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 354980, BIOMET SPLINED KNEE STEM CATALOG 148306 LOT 731640, BIOMET 360 TIBIAL TRAY CATALOG 185206 LOT 184200, BIOMET SPLINED KNEE STEM CATALOG 148306 LOT 277800, BIOMET 360 OFFSET ADAPTER CATALOG 185211 LOT 497570, VANGUARD SSK TIBIAL BEARING CATALOG 185104 LOT 985950, UNKNOWN COBALT BONE CEMENT. CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION ARTHROPLASTY APPROXIMATELY THREE YEARS POST IMPLANTATION DUE TO PAIN AND LOOSENING OF THE FEMORAL COMPONENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.