inforMED
InjuryMBV

BIOMET SPLINED KNEE STEM V2

Received Aug 4, 2020 · Event occurred Jul 16, 2020

Report 0001825034-2020-03043 · MDR key 10363219

Device

Generic name

Prosthesis, Knee

Model number

N/A

Catalog number

148311

Lot number

423070

Product problems

  • Loss of or Failure to Bond
  • Loss of or Failure to Bond

Patient

66 YR

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

(B)(4). MEDICAL PRODUCT: VNGD SSK 360 L FEM 65MM CATALOG # 185284 LOT # 6002316. BMT 360 TIB AUG 71X10MM CATALOG # 185233 LOT # 214680. BMT SPLINED KNEE STM V2 18X80 CATALOG # 148308 LOT # 047290. BMT 360 TIB TRAY 71MM CATALOG # 185203 LOT # 747320. VG 360 DST FM AG 65X5 LL/RM CATALOG # 185324 LOT # 180890. BMT 360 7.5MM OFFSET ADAPTER CATALOG # 185212 LOT # 289130. BMT 360 7.5MM OFFSET ADAPTER CATALOG # 185212 LOT # 590200. VNGD SSK PS TIB BRG 12X71/75 CATALOG # 185082 LOT # 254560. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-03029. 0001825034-2020-03036. 0001825034-2020-03037. 0001825034-2020-03041. 0001825034-2020-03042.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G4, G7, H1, H2, H3, H6, H10. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. X-RAY REVIEW INDICATES THAT LEFT TOTAL KNEE ARTHROPLASTY IS SEEN IN PLACE WITH CORTICAL THICKENING OF THE DISTAL FEMORAL DIAPHYSIS POSSIBLY INDICATING FEMORAL COMPONENT LOOSENING. NO JOINT EFFUSION. TIBIAL COMPONENT DEMONSTRATES RADIOLUCENCY AT THE BONE CEMENT INTERFACE, ALSO POSSIBLY INDICATING LOOSENING. THERE IS ALSO RADIOLUCENCY AT THE BONE CEMENT INTERFACE OF THE PATELLAR COMPONENT. OVERALL FIT AND ALIGNMENT OF THE IMPLANTS IS APPROPRIATE. OSTEOPENIA IS PRESENT DIFFUSELY. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.