Duracon 6478-6-438Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327044775), received between Jun 10, 2020 and Aug 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2023Fracture; Fracture

  PATIENT REPORTED THAT ALLEGEDLY HIS TIBIAL STEM CRACKED AND REQUIRES REVISION SURGERY. THE PATIENT HAS NOT BEEN REVISED. (LEFT KNEE). UPDATE 01/12/24: PER MED REVIEW "THE LAST SURGERY ON (B)(6), 2023, WAS A REVISION OF ALL COMPONENTS USING A COMPETITOR IMPLANT."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 17587512 ↗
• InjuryJun 10, 2020Fracture; Fracture

  MRH IMPLANT REMOVED, KNEE REVISION. DAMAGE WAS SEEN ON PARTS CONNECTING THE MRH FEMORAL PART WITH EXTENSION. UPDATE: "REMOVAL OF A DAMAGED DENTURE. FRACTURE AND DETACHMENT AT THE FEMORAL AND MANDREL JUNCTION LEVEL. MRH / GMRS KNEE REVISION. EXCHANGE ON GMRS. PLEASE ESTIMATE ANY SURGICAL DELAY, EVEN IF UNDER A MINUTE : 30 MIN. THE PRODUCT HAS BEEN DAMAGED DURING USE, I.E. IN THE PATIENT'S BODY. THE FIRST IMPLANTATION TOOK PLACE IN 2014. THE PATIENT WAS 28 YEARS OLD. THEN THE PATIENT REPORTED PAIN. THE DECISION WAS MADE TO REPLACE THE PRIMARY IMPLANT. REVISION SURGERY WAS ON (B)(6) (REMOVAL OF DAMAGED ELEMENTS, EXCHANGE FOR NEW ONE)."

  Patient problems: Injury; Pain

  MAUDE report 10137693 ↗