Kinemax 6476-8-260Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327045352), received between May 22, 2017 and Jul 29, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K223069, K896452, K904208); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Fracture

  The following information was provided: The patient went to the doctor complaining of instability and said there had been a cracking sound during the night. Additional information received indicates fracture of the device.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 50070607 ↗
• InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PAIN AND LOOSENING ON X-RAY. ALL AVAILABLE INFORMATION SUBMITTED." MEDICAL REVIEW STATES INFECTION. ADDITIONAL INFORMATION: THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR A GIANT CELL TUMOR AND HAD A PROXIMAL TIBIAL REPLACEMENT. SUBSEQUENTLY NINE YEARS LATER THE PATIENT DEVELOPED A PERIPROSTHETIC INFECTION. A TWO STAGE REVISION WAS CARRIED OUT. THE INITIAL CULTURE GREW OUT STREPTOCOCCUS. AN ANTIBIOTIC IMPREGNATED SPACER WAS APPLIED AND THEN REIMPLANTATION WAS CARRIED OUT ON (B)(6) 2025.

  Patient problems: Bacterial Infection; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 21710116 ↗
• InjuryMar 21, 2024Loss of Osseointegration; Detachment of Device or Device Component; Device Dislodged or Dislocated; Loss of Osseointegration; Detachment of Device or Device Component; Device Dislodged or Dislocated

  REVISION OF DISTAL FEMORAL GMRS WITH MRH TIBIA. DIAGNOSIS FOR REVISION WAS LYSIS AND SUSPECTED FEMORAL STEM LOOSENING. INTRA-OP, THE SURGEON COMMENTED THAT THE TIBIAL CONSTRUCT WAS LOOSE AND ALSO NEEDED TO BE REMOVED. WHEN REMOVING THE TIBIAL CONSTRUCT, THE SURGEON COMMENTED THAT THE STEM WAS NOT TIGHT ON THE BASEPLATE AND WAS FREELY MOVING (UNTHREADING). ISSUE NOTICED AFTER PRIMARY PROCEDURE, PRIOR TO REVISION PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Joint Dislocation; Osteolysis

  MAUDE report 18955506 ↗
• InjuryJun 22, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION OF TIBIAL COMPONENT FOR ASEPTIC LOOSENING.

  Patient problems: Injury

  MAUDE report 10178706 ↗
• MalfunctionMay 22, 2017Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  DURING A REVISION KNEE WHEN IT WAS TIME TO OPEN THE IMPLANTS THE SURGEON AND REP IN THE ROOM NOTICED A POWDER LIKE SUBSTANCE ON THE FEMORAL IMPLANT. THEY THEN OPENED TWO STEMS AND BOTH STEMS HAD THE SAME RESIDUE. A SECOND FEMORAL IMPLANT WAS RUSHED TO THE HOSPITAL AND ONCE AGAIN WAS FOUND TO HAVE THE SAME RESIDUE ON THE IMPLANT. THE SURGEON WAS OBVIOUSLY VERY UPSET BY THIS AND HAD TO SOAK THE IMPLANTS IN BETADINE BEFORE FINALLY IMPLANTING THEM AS THERE WERE NO OTHER ALTERNATIVES. THESE IMPLANTS ALL CAME FROM "NATIONAL LOANERS."

  Patient problems: No Information

  MAUDE report 6583527 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223069, K896452, K904208. One submission often covers many models, so check the product and lot details in each record.

• Z-1614-2015 · Feb 27, 2015 · Terminated
  Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modul