MRH 6481-1-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327045178), received between Aug 31, 2020 and Aug 6, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

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

  THIS PI IS FOR THE ORIF DUE TO PERIPROSTHETIC FRACTURE. INFORMATION RECEIVED FROM IIS (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: Bone Fracture(s)

  MAUDE report 22724335 ↗
• InjuryMar 26, 2025Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  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 21702994 ↗
• InjuryAug 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT HAD INDEX SURGERY LEFT TKA OUTSIDE CORS SCOPE. THE PATIENT DEVELOPED A MECHANICAL FAILURE AND UNDERWENT A LEFT TOTAL KNEE REVISION (B)(6) 2016. PATIENT RETURNS FOR FAILED LEFT TOTAL KNEE ARTHROPLASTY. TIBIAL YOKE FRACTURE, METALLOSIS AND PATELLAR COMPONENT LOOSE. PATIENT UNDERGOES NEW LEFT KNEE REVISION ON (B)(6) 2020. FEMORAL AND HINGE COMPONENTS EXCHANGED.

  Patient problems: Injury

  MAUDE report 10473403 ↗