MRH 6481-3-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327045307), received between Sep 11, 2017 and Aug 6, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 14 most recent of 14 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

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: AT THE TIME OF DOCUMENTATION OF SURGERY, NOTE ALSO MENTIONS R TIBIA FRACTURE WITH TIGHTENING OF ACHILLES TENDON THAT IS BEING TREATED BY AN OUTSIDE PHYSICIAN WITH SERIAL CASTING. NO COMPONENTS WERE REMOVED. RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22733065 ↗
• InjuryAug 6, 2025Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 22733060 ↗
• 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: NONUNION OF IMPLANT PROXIMALLY AND DISTAL TIBIA FRACTURE W/ MALUNION/NON-UNION. R ABOVE KNEE AMPUTATION PERFORMED.

  Patient problems: Bone Fracture(s)

  MAUDE report 22726909 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR THE TREATMENT OF CELLULITIS. INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: CELLULITIS. DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION ON 9/10/2012, CULTURED FOR ENTEROBACTER, ORAL LEVAQUIN AND IV ANTIBIOTIC. THEN PERIPROSTHETIC FRACTURE TIBIA. L TIBIAL COMPONENTS REMOVED 07/30/2014. LEFT KNEE.

  Patient problems: Cellulitis

  MAUDE report 22717586 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR REVISION DUE TO PERIPROSTHETIC FRACTURE. INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: CELLULITIS. DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION ON (B)(6) 2012, CULTURED FOR ENTEROBACTER, ORAL LEVAQUIN AND IV ANTIBIOTIC. THEN PERIPROSTHETIC FRACTURE TIBIA. L TIBIAL COMPONENTS REMOVED (B)(6) 2014. LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22716270 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: FOOT DROP AND LOSS OF SENSATION IN FOOT. NON-SURGICAL TREATMENT. PER (B)(6) 2014, MOTOR FUNCTION IMPROVED BUT SENSATION DID NOT FULLY RETURN. LEFT KNEE.

  Patient problems: Numbness

  MAUDE report 22713503 ↗
• InjuryJul 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 22673405 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. NO OTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12757917 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REP WAS NOTIFIED THAT THERE WERE EXPLANTS READY TO BE PICKED UP AT THE SURGEON'S REQUEST. THE SURGEON IS NOT A STRYKER USER AND WILL RELEASE NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603058 ↗
• InjuryMar 30, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT SPECIFIC SOLUTIONS REQUEST WAS RECEIVED FOR THE PATIENT'S RIGHT DISTAL FEMUR WITH NOTES: "UNDERWENT CONSTRAINED TKA WITH STRYKER COMPONENTS AND AFTER INITIAL POSTOP PERIOD OF DOING WELL HAS HAD PERSISTENT OSTEOLYSIS, PAIN AND DECREASING FUNCTION. ALLERGY TESTING REVEALED NICKEL ALLERGY AND MULTIPLE BLOOD AND ASPIRATIONS OF THE JOINT HAVE BEEN NEGATIVE FOR INFECTION." A NICKEL FREE DISTAL FREE FEMUR IMPLANT IS BEING REQUESTED WITH A PLANNED DATE OF SURGERY (B)(6) 2021.

  Patient problems: Inflammation; Pain

  MAUDE report 11592228 ↗
• InjuryFeb 28, 2019Break; Fracture; Break; Fracture

  PATIENT HAD A REVISION SURGERY DUE TO FRACTURE OF THE TIBIAL BASEPLATE.

  Patient problems: Injury

  MAUDE report 8378849 ↗
• InjuryOct 1, 2018Fracture; Noise, Audible; Fracture; Noise, Audible

  END USER HAS REPORTED THAT FOR THE PATIENT THERE IS PAIN AND CLICKING SOUND WHEN STANDING (FROM FLEXION TO EXTENSION). THE PATIENT CLAIMS THAT HE NEEDS TO SWING HIS LEFT MULTIPLE TIMES UNTIL HE ACHIEVES FILL EXTENSION. THIS RESULTED INTO A FALL AND FRACTURING THE PROXIMAL TIBIA. A PROXIMAL TIBIA (GMRS) WAS IMPLANTED ON THE 1ST WEEK OF (B)(6) 2018. FIRST SURGERY (B)(6) 2012¿¿ MRH (ROTATING HINGED KNEE). SECOND SURGERY (B)(6) 2014¿¿¿¿.. DISTAL FEMUR REPLACEMENT (GMRS). THIRD SURGERY (B)(6) 2018¿¿¿¿¿¿ PROXIMAL TIBIA REPLACEMENT (GMRS). FURTHER UPDATE FROM THE DISTRIBUTOR: IT WAS IDENTIFIED AFTER 4 YEARS THAT THE PATIENT WAS COMPLAINING ABOUT A CLICKING DURING MOTION. AFTER AN X-RAY DONE, THE PROSTHESES SLIPPED OFF ONE FROM ANOTHER AND BROKE THE PATIENT'S TIBIA.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 7922203 ↗
• InjurySep 25, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMUR AND TIBIA, AS WELL AS A BROKEN FEMORAL STEM AT THE STEM/ OFFSET BOLT INTERFACE. REP REPORTED THE PATIENT'S ENTIRE KNEE WAS REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7908432 ↗
• InjurySep 11, 2017Loss of Osseointegration; Loss of Osseointegration

  PATIENT STATED THAT ON OR ABOUT (B)(6) 2016, SHE STARTED EXPERIENCING PAIN AGAIN. PATIENT WENT TO A DOCTOR AND IT WAS FOUND THAT THE TIBIA WAS LOOSE AGAIN AND SHE HAD AN INFECTION. ON (B)(6) 2016 SHE HAD A REVISION.

  Patient problems: Inadequate Osseointegration; Injury; Pain; Unspecified Infection

  MAUDE report 6855931 ↗