MRH 6481-1-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327045147), received between Nov 11, 2019 and Aug 24, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Fracture” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2026Fracture

  Patient problems: Insufficient Information

  MAUDE report 50416220 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: RIGHT KNEE HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 22724325 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: PROSTHETIC JOINT INFECTION. ABOVE KNEE AMPUTATION PERFORMED. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22724282 ↗
• InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: LOOSENING. ADVISED AGAINST SURGERY. NO COMPONENTS WERE REMOVED. RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22713665 ↗
• InjuryJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: PATELLAR TENDON RUPTURE. NO COMPONENTS REMOVED. RIGHT KNEE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22680678 ↗
• InjurySep 24, 2023Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HINGED KNEE WAS REVISED AFTER PATIENT COMPLAINT OF THIGH PAIN. SURGEON ORIGINALLY SUSPECTED FEMORAL LOOSENING. HOWEVER, INTRA-OP IT WAS OBSERVED THAT THE LATERAL CONDYLE OF THE FEMORAL COMPONENT BROKE OFF OF THE IMPLANT AND WAS LOOSE IN THE JOINT.

  Patient problems: Pain

  MAUDE report 17805312 ↗
• InjuryJul 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGEON REPORTED THE NON-CONNECTION BETWEEN THE FEMORAL COMPONENT AND THE TAPROOT. POLIO PATIENT TREATED 3 MONTHS AGO FOR REVISION OF KNEE PROSTHESIS BY AFFIXING OF MRH SYSTEM. ABOUT THREE MONTHS AFTER THE OPERATION, THE PATIENT RETURNS FOR EXAMINATION AND THE COMPLETE DECOUPLING BETWEEN THE STEM AND THE FEMORAL COMPONENT IS DETECTED BY RADIOGRAPHIC EXAMINATION. THE FEMORAL PART WAS REVISED USING THE GMRS SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 17350154 ↗
• InjuryAug 11, 2021Fracture; Fracture

  IT HAS BEEN REPORTED "PATIENT MRH FEMORAL IMPLANT WAS BROKEN AND ONLY FOUND DURING THE SURGERY ON (B)(6) 2021. THE LAST REVISION DONE AROUND 2015".

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12310006 ↗
• InjuryApr 8, 2021Fracture; Fracture

  PATIENT HAD MRH KNEE IMPLANTED. THE STEM/FEMUR INTERFACE APPEARED DAMAGED. FEMORAL COMPONENT REVISED TO GMRS DISTAL FEMUR. SPOKE TO REP. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED AUGMENTS AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 11634193 ↗
• InjuryMar 4, 2021Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  REVISION OF TOTAL KNEE FOR PAIN.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain

  MAUDE report 11417681 ↗
• InjurySep 9, 2020Fracture; Fracture

  FRACTURED RIGHT MRH FEMUR COMPONENT. THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2007. IT HAS ALREADY BEEN REVISED ON (B)(6) 2011 AND (B)(6) 2015. NOW THE THIRD REVISION WILL BE PERFORMED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 10507788 ↗
• InjuryJan 14, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  PROTHEOS DISTRIBUTOR REPORTED THAT : "MRH FEMORAL HOUSING FAILURE" FIRST IMPLANTATION (B)(6) 2013. SECOND INTERVENTION (B)(6) 2014. REVISION SURGERY : (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 9588307 ↗
• InjuryNov 11, 2019Fracture; Fracture

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT EXPERIENCED PROBLEMS WITH THIS DEVICE IN (B)(6) 2018. IT IS FURTHER ALLEGED THAT DUE TO PAIN WITH WEIGHT BEARING A WORK UP WAS DONE AND THE PROSTHETIC CRACKED AND FRACTURED ALONG THE FEMORAL COMPONENT NEAT OR AT THE LOCATION OF THE HINGE. THE PATIENT WAS REVISED ON (B)(6) 2018.

  Patient problems: Injury; Pain

  MAUDE report 9305290 ↗