Duracon 6742-4-222Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327049565), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K021451, K032163, K032418); 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 18, 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.

• InjurySep 23, 2019Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Insufficient Device Problem Information; Material Erosion; Detachment of Device or Device Component; Device Dislodged or Dislocated; Insufficient Device Problem Information

  RESOURCE COORDINATOR CALLED INQUIRING ABOUT A RECALL ON A PATIENT'S RIGHT KNEE REVISION DUE TO A FAILED IMPLANT. NO FURTHER INFORMATION WAS PROVIDED. UPDATE 27-AUG-2019: AS PER LEGAL: IT WAS REPORTED BY THE PATIENT THAT HE UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE WHERE HE WAS IMPLANTED WITH AN UNKNOWN KNEE SYSTEM. IT IS FURTHER ALLEGED THAT HE UNDERWENT REVISION SURGERY ON (B)(6) 2014 DUE TO PAIN WHERE HE WAS IMPLANTED WITH A STRYKER ARTICULAR INSERT AND CEMENT SIMPLEX HV WITH GENTAMICIN WAS USED.

  Patient problems: Ambulation or Postural Difficulties; Injury; Osteolysis; Pain; Subluxation

  MAUDE report 9105398 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021451, K032163, K032418. One submission often covers many models, so check the product and lot details in each record.

• Z-0916-2024 · Dec 1, 2023 · Open, Classified
  DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
• Z-0917-2024 · Dec 1, 2023 · Open, Classified
  DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
• Z-0918-2024 · Dec 1, 2023 · Open, Classified
  DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200