VG 360 UNIV PST FM AUG 75X10
Received Dec 10, 2019 · Event occurred Sep 19, 2019
Report 0001825034-2019-05518 · MDR key 9446768
Device
Generic name
Prosthesis, Knee
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
185428
Lot number
723710
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
Not reported
- Erosion
- Pain
- Erosion
- Pain
Narrative
Additional Manufacturer Narrative
CONCOMITANT MEDICAL PRODUCTS: BIOMET SPLINED KNEE STEM CATALOG 141878 LOT 039130, VANGUARD FEMORAL COMPONENT 185288 LOT 3422678, VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 408680, TIBIAL BEARING LOT 985950, BIOMET TIBIAL LOCKING BAR CATALOG 141205 LOT 884680, BIOMET 360 TIBIAL TRAY CATALOG 185206 LOT 184200, BIOMET SPLINED KNEE STEM CATALOG 148306 LOT 277800, BIOMET 60 OFFSET ADAPTER CATALOG 185211 LOT 497570, UNKNOWN COBALT BONE CEMENT. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. CLINICAL NOTES FOUND THAT PATIENT HAD ONGOING KNEE PAINS; BONE SCAN SHOWS UPTAKE OVER FEMORAL COMPONENT SUGGESTING LOOSENING; DIAGNOSED WITH ASEPTIC FAILURE AND SEVERE BONE LOSS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
Description of Event or Problem
NO ADDITIONAL INFORMATION REPORTED.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET SPLINED KNEE STEM CATALOG 141658 LOT 039130, UNKNOWN FEMORAL COMPONENT LOT 3422678, VANGUARD 360 FEMORAL AUGMENT CATALOG 185428 LOT 408680, TIBIAL BEARING LOT 985950, BIOMET TIBIAL LOCKING BAR CATALOG 141205 LOT 884680, BIOMET 360 TIBIAL TRAY CATALOG 185206 LOT 184200, BIOMET SPLINED KNEE STEM CATALOG 148306 LOT 277800, BIOMET 360 OFFSET ADAPTER CATALOG 185211 LOT 497570, UNKNOWN COBALT BONE CEMENT. THE PRODUCT HAS NOT BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT STILL REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE PATIENT HAS BEEN INDICATED FOR A LEFT KNEE REVISION ARTHROPLASTY APPROXIMATELY 18 MONTHS POST IMPLANTATION DUE TO ONGOING FEMORAL ASEPTIC FEMORAL LOOSENING WITH SEVERE BONE LOSS. NO REVISION HAS BEEN REPORTED TO DATE.