Duracon 6478-6-665Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327044973), received between Jul 12, 2018 and Aug 6, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K223069, K973164); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: R TOTAL KNEE REVISION FOR PATELLAR DISPLACEMENT ON (B)(6) 2014. ALL COMPONENTS REMOVED. ALSO HAD IPSILATERAL ANKLE FRACTURE BETWEEN GMRS SURGERY AND LAST F/U VISIT WHERE FEMORAL STEM LOOSENING WAS DIAGNOSED. DECLINED DISCUSSION OF SURGERY AT LAST VISIT. HAD ORDER FOR PT AND PLAN WAS TO CONTINUE W THIS.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 22733554 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE STAGE 1 REVISION DUE TO INFECTION. INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ON (B)(6) 2015 HAD A FRACTURE ON FEMUR SIDE REQUIRING ORIF WHICH GOT INFECTED. ENTIRE FEMORAL AND TIBIAL COMPONENT REMOVED AND SPACER PLACED (B)(6) 2015. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22724338 ↗
• InjuryJul 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S LEFT KNEE DUE TO ELEVATED TITANIUM IONS. INTRA-OPERATIVELY, SURGEON REPORTED THAT THE TITANIUM FEMORAL STEM WAS LOOSE. THE PATIENT'S ENTIRE MRH CONSTRUCT WAS REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10238337 ↗
• InjuryFeb 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ITS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT KNEE SURGERY ON (B)(6) 2016 DUE TO A FRACTURED LEFT PROXIMAL TIBIAL ALLOGRAFT, CATASTROPHIC FAILURE, LEFT ALLOPROSTHETIC ARTHROPLASTY. IT'S FURTHER ALLEGED THAT THE PATIENT UNDERWENT ONE STAGE LEFT KNEE ENDOPROSTHETIC REVISION, RADICAL SYNOVECTOMY ON (B)(6) 2019 DUE TO INFECTION.

  Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

  MAUDE report 9696420 ↗
• InjuryApr 15, 2019Osseointegration Problem; Osseointegration Problem

  LOOSENING OF THE MRH PROSTHESIS IN THE FEMORAL AREA. STEM LOOSENED FROM FEMUR.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8514605 ↗
• InjuryJul 12, 2018Osseointegration Problem; Osseointegration Problem

  AFTER IMPLANT WAS REMOVED, IT WAS NOTICED THAT THE STEM WAS LOSE AND THE WAS A CRACK ON THE CONNECTION BETWEEN STEM AND FEMUR COMPONENT.

  Patient problems: Injury

  MAUDE report 7682072 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223069, K973164. One submission often covers many models, so check the product and lot details in each record.

• Z-0362-2016 · Sep 21, 2015 · Terminated
  Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, m