AGC KNEE SYSTEM 155362Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304007772), received between Apr 20, 2021 and Apr 20, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K921182); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Inadequate Osseointegration; Muscle/Tendon Damage; Scar Tissue

  MAUDE report 11692384 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K921182. One submission often covers many models, so check the product and lot details in each record.

• Z-2149-2020 · Apr 17, 2020 · Terminated
  Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee S
• Z-0077-2008 · Jul 24, 2007 · Terminated
  Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
• Z-0076-2008 · Jul 24, 2007 · Terminated
  Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 15