MRH 6481-1-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327045130), received between May 19, 2017 and Nov 13, 2025 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Pain

  MAUDE report 23543622 ↗
• 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: ARTHROFIBROSIS. REQUIRED MANIPULATION UNDER ANESTHESIA. LEFT KNEE.

  Patient problems: Arthrofibrosis

  MAUDE report 22724388 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE ROTATIONAL FLAP. INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: PATELLAR TENDON RUPTURE. REQUIRED ROTATIONAL FLAP (B)(6) 2013. ALL COMPONENTS REMOVED FOR INSTABILITY (B)(6) 2018. LEFT KNEE.

  Patient problems: Rupture

  MAUDE report 22724386 ↗
• InjuryAug 6, 2025Unstable; Unstable

  THIS PI IS FOR THE REVISION FOR INSTABILITY. INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: PATELLAR TENDON RUPTURE. REQUIRED ROTATIONAL FLAP (B)(6) 2013. ALL COMPONENTS REMOVED FOR INSTABILITY(B)(6) 2018. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22724385 ↗
• 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: PATELLAR TENDON RUPTURE. REQUIRED OPEN REPAIR. LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22724329 ↗
• 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: PERIPROSTHETIC FX OF FEMUR. FEMORAL COMPONENTS REMOVED. LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22724328 ↗
• InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22720211 ↗
• InjuryMay 27, 2024Fracture; Fracture

  REVISION SURGERY MRH FEMUR, GMRS PROXIMAL TIBIA. CONDYLE LATERAL OF MRH FEMUR DISCOVERED TO BE BROKEN. REVISION SURGERY TO DISTAL FEMUR REPLACEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400270 ↗
• InjuryJul 31, 2023Fracture; Fracture

  FIRST REVISION TO DISTAL FEMUR DUE TO MRH KNEE FEMORAL BUSHING P.E. WEAR, + BROKEN METALLIC MECHANICAL FAILURE OF LATERAL FEMORAL CONDYLE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 17422644 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT: "PRODUCT: PTG TYPE GMRS STRYKER (INSTALLED IN 2018) DEAR MADAM/SIR, ONE OF YOUR KNEE PROSTHESIS HAS BEEN THE SUBJECT OF A CASE OF EXPOSURE RECORDED BY THE FRENCH POISON CONTROL AND TOXICOVIGILANCE CENTERS. IN ACCORDANCE WITH ARTICLE R1341-2 OF THE FRENCH PUBLIC HEALTH CODE, WE WOULD BE GRATEFUL IF YOU COULD PROVIDE US WITH THE FOLLOWING INFORMATION AS SOON AS POSSIBLE - THE COMPLETE QUALITATIVE AND QUANTITATIVE COMPOSITION AT 100%: O TO REMOVE ANY AMBIGUITY, EACH SUBSTANCE WILL BE IDENTIFIED BY A CAS OR EN NUMBER, O THE CONCENTRATION OF EACH SUBSTANCE WILL BE DESIGNATED QUANTITATIVELY BY A PRECISE CONCENTRATION OR SEMI-QUANTITATIVELY BY AN ACCEPTABLE CONCENTRATION RANGE. O IF SOME OF THE COMPONENTS OF YOUR MIXTURE ARE THEMSELVES INCLUDED MIXTURES SUPPLIED BY OTHER MANUFACTURERS, THEY SHOULD BE LISTED IN THE COMPOSITION UNDER THEIR TRADE NAME AND THE CORRESPONDING SAFETY DATA SHEET SHOULD BE PROVIDED TO US. THIS INFORMATION IS ESSENTIAL FOR US TO EVALUATE THE RISKS AND TO PROPOSE AN ADAPTED MEDICAL CARE FOR THE EXPOSED PERSONS WHO ARE IN SITUATIONS VERY FAR FROM THE EXPECTED USE OF THE MENTIONED MIXTURE." "THIS CASE IS A BIT SPECIAL BECAUSE THE PATIENT CO

  Patient problems: Fistula; Foreign Body Reaction; Inflammation; Metal Related Pathology; Osteomyelitis; Unspecified Infection; Wound Dehiscence

  MAUDE report 13584432 ↗
• InjurySep 21, 2021Break; Fracture; Break; Fracture

  THE FOLLOWING WAS REPORTED: FEMORAL IMPLANT RUPTURE AT THE JUNCTION BETWEEN KEEL AND FEMORAL SHIELD. REVISION SURGERY REQUIRED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12506202 ↗
• InjuryMar 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "STEM LOOSENING AT THE BOSS JUNCTION. (REVISED COMPONENTS) SMALL MRH FEMUR WITH 10MM AUGMENTS MEDIAL LATERAL, 10X80 STEM AND MODULAR COMPONENTS." SPOKE TO REP. THE STEM WAS BEGINNING TO COME UNTHREADED FROM THE FEMORAL COMPONENTS. THERE ARE NO ALLEGATIONS AGAINST THE REVISED AUGMENTS OR MODULAR COMPONENTS. AN MRH FEMORAL COMPONENT WITH STEM, AUGMENTS AND BLOCKS, TIBIAL SLEEVE, INSERT, AND TIBIAL ROTATING COMPONENT WERE IMPLANTED, AND THE PATIENT'S NATIVE PATELLA WAS RESURFACED. REP PROVIDED USAGE SHEETS FOR PRIMARY AND REVISION, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11447726 ↗
• InjuryFeb 12, 2020Fracture; Fracture

  AS REPORTED: "PATIENT REQUIRED REVISING DUE TO FRACTURE OF THE MRH FEMUR COMPONENT FOLLOWING A FALL." AN MRH FEMORAL COMPONENT, STEM, BUSHINTS, TIBIAL SLEEVE, BUMPER, AND INSERT WERE REVISED IN THE PATIENT'S LEFT KNEE. SPOKE TO REP. THE PATIENT'S BONE DID NOT FRACTURE.

  Patient problems: Injury

  MAUDE report 9702558 ↗
• InjuryJan 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF FEMORAL PAIN. INTRA-OPERATIVELY, THE CONDYLE OF THE MRH FEMORAL COMPONENT WAS FOUND TO BE COMPLETELY BROKEN OFF. REP PROVIDED PICTURES OF THE EXPLANTS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 9560327 ↗
• InjuryNov 20, 2019Unstable; Unstable

  IT WAS REPORTED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2012 WHERE SHE WAS IMPLANTED WITH A STRYKER MRH KNEE FEMORAL COMPONENT. IT IS FURTHER ALLEGED THAT AFTER IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN AND INSTABILITY. THE PATIENT UNDERWENT REVISION SURGERY OF HER LEFT KNEE ON (B)(6) 2018.

  Patient problems: Injury; Pain

  MAUDE report 9347658 ↗
• InjuryOct 9, 2018Mechanical Problem; Loss of Osseointegration; Mechanical Problem; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO MECHANICAL FAILURE AND LOOSENING (SURGEON WOULD NOT REPORT MORE THAN THAT TO THE REP). AN MRH CONSTRUCT OF 11 DEVICES EXCEPT THE TIBIAL BASEPLATE WAS REVISED TO AN MRH CONSTRUCT WITH AN ADDITIONAL CONE AUGMENT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7948434 ↗
• MalfunctionJul 13, 2017Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROSTHESIS SURGERY IT WAS OBSERVED THAT THE FIRST PLASTIC PACKAGING WAS TORN ALONG THE ENTIRE LENGTH ON ONE SIDE AND THE SECOND INTERNAL PLASTIC PACKAGING WAS NOT DAMAGED. AS THERE WERE NO OTHER AVAILABLE DEVICES, THE SURGEON MADE THE DECISION TO IMPLANT THE DEVICE IN SPITE OF THE DAMAGED FIRST PLASTIC PACKAGING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6711402 ↗
• 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 6583532 ↗
• MalfunctionMay 19, 2017Device Damaged Prior to Use; Contamination of Device Ingredient or Reagent; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  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 Consequences Or Impact To Patient; No Information

  MAUDE report 6579819 ↗