MRH 6481-1-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327045109), received between Feb 11, 2020 and Nov 17, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE STEM BREAKING AT THE JUNCTION WITH THE FEMORAL COMPONENT OF A HINGED KNEE CONSTRUCT. REVISING SURGEON REPORTED HE FEELS THE FEMORAL SIDE SHOULD HAVE BEEN A DISTAL FEMORAL REPLACEMENT. THE PATIENT'S MRS/ MRH KNEE COMPONENTS (EXCEPT FOR THE PROXIMAL TIBIAL COMPONENT AND STEM) WERE REVISED. REP PROVIDED ALL INFORMATION THAT WAS AVAILABLE FROM THE HOSPITAL AND SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 18158259 ↗
• InjuryMar 30, 2023Fracture; Loss of Osseointegration; Device Dislodged or Dislocated; Fracture; Loss of Osseointegration; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: "PATIENT PRESENTED ON (B)(6) 2022 ORTHOPAEDICS CLINIC OUTPATIENT CLINIC FOR SECOND OPINION. DIAGNOSIS BY CT, SCINTIGRAPHY AND X-RAY. LOOSENING KNEE TEP LEFT WITH PATHOLOGICAL MOBILITY KNEE LEFT WITH FRACTURE OF FEMORAL CONDYLE (STRYKER REVISION PROSTHESIS). REVISION SURGERY ON (B)(6) 2023 WITH EXPLANTATION FEMORAL SHIELD AND MOBILE PARTS TIBIAL, EXTENSIVE SYNOVECTOMY, PALACOSSPAC INSERTION KNEE LEFT. CONDITION AFTER TIBIAL PLATEAU FRACTURE 2012 LEFT, CONDITION AFTER KNEE TEP IMPLANTATION 2013, CONDITION AFTER KNEE TEP REPLACEMENT 2016, CONDITION AFTER KNEE TEP REPLACEMENT 2018, CONDITION AFTER IMPLANTATION RETROPATELLAR KNEE REPLACEMENT 2020."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16642213 ↗
• InjuryDec 15, 2022Loss of Osseointegration; Loss of Osseointegration

  PATIENT UNDERWENT PRIMARY LEFT TKA OUTSIDE OF CORS SCOPE. ON (B)(6), 2019, PATIENT WAS REVISED FOR MECHANICAL ISSUES. PATIENT PRESENTED AGAIN WITH PAIN AND SIGNS OF FEMORAL LOOSENING. WAS REVISED ON (B)(6) 2022. ALL COMPONENTS WERE EXCHANGED EXCEPT TIBIAL COMPONENTS.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15986080 ↗
• InjuryDec 12, 2022Fracture; Fracture

  AT THE OUTPATIENT CHECK-UP ON (B)(6) 2022, THE X-RAYS SHOWED RUPTURE OF THE FEMORAL STEM WITH A DISCONNECTION BETWEEN THE MRH COMPONENT OF THE FEMORAL PROSTHETIC SHIELD AND THE FEMORAL STEM. ON (B)(6) 2022, THE COMPLETE REVISION SURGERY OF THE MRH SIZE SMALL FEMORAL COMPONENT AND NEW 15X155MM FEMORAL STEM WERE PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 15964906 ↗
• InjuryJul 7, 2022Fracture; Fracture

  THE FOLLOWING WAS REPORTED THROUGH: THE SHIELD OF THE FEMORAL COMPONENT IS BROKEN AND HAD TO BE REPLACED. EXPLANATION BY SALES REP: LATERAL CONDYLAR FRACTURE AT THE FEMORAL COMPONENT OF THE MRH JOINT REPLACEMENT.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 14941923 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE (B)(6) 2020 REVISION. PATIENT UNDERWENT PRIMARY TKA OUTSIDE OF CORS SCOPE. HAD A REVISION TKA ON (B)(6) 2020 FOR PJI. PATIENT HAD A FALL PLUS SUBLUXATION OF THE PATELLA, SHE ALSO HAD SYMPTOMS OF REINFECTION OF THE LEFT KNEE. A REVISION WAS PERFORMED ON (B)(6) 2020, A PERIPROSTHETIC FRACTURE B1 OF THE FEMUR WAS OBSERVED, AND MALTRAKING OF THE PATELLA. ALL COMPONENTS WERE EXCHANGED EXCEPT THE TIBIAL STEM.

  Patient problems: Bone Fracture(s); Subluxation; Unspecified Infection

  MAUDE report 11375072 ↗
• InjuryJul 13, 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 10268725 ↗
• 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 9693545 ↗