MRH 6481-3-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327043822), received between Feb 22, 2019 and May 28, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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.

• InjuryMay 28, 2026Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT UPON REVISION, POLYETHYLENE WEAR WAS OBSERVED ON THE TIBIAL SLEEVE, TIBIAL INSERT, BUMPER. ROTATING COMPONENT, DISTAL FEMUR. PATIENT REVISED DUE TO RIGHT KNEE INSTABILITY. PATIENT REVISED WITH NEW, ANALAGOUS COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 25314903 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT AFTER IMPLANTATION OF A DISTAL FEMORAL CONSTRUCT INCLUDING CUSTOM IMPLANTS, PATIENT HAS DEVELOPED AN INFECTION. SURGEON'S PLAN IS TO REMOVE ALL IMPLANTS EXCEPT THE RESTORATION MODULAR STEM (USED IN THE DISTAL FEMUR). FOR THE CUSTOM GMRS RESTORATION MODULAR ADAPTER AND CUSTOM LOCKING BOLT, SURGEON'S PLAN IS TO REMOVE THE DEVICES, WASH THEM IN BETADINE, AND RE-IMPLANT THEM. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 25147072 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION MRH DUE TO INFECTION. WASHOUT PROCEDURE AND MINOR REVISION. NO STRYKER REPRESENTATIVE PRESENT. INFORMED BY NURSING STAFF AFTER THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25019014 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION LTKA - CHANGING ALL THE MOVABLE PARTS DUE TO INFECTION." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19358074 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REV RTKA - CHANGING ALL MOVEABLE PARTS AND WENT UP ON THE POLY FOR INFECTION AND NOW PLACING FLAPS FOR SKIN CLOSURE." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19017669 ↗
• InjuryJan 2, 2024Adverse 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 DETERMINED THAT THE PATIENT HAD A SURGERY WHERE THE INSERT, BUSHINGS, SLEEVE, BUMPER AND ROTATING COMPONENT WERE REVISED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 18432586 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SURGEON PERFORMED AN I&D/WASHOUT AND SWAPPED OUT ALL OF THE POLY COMPONENTS IN THE PROCESS. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES.

  Patient problems: Unspecified Infection

  MAUDE report 17001117 ↗
• InjuryOct 27, 2021Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT PRESENTED WITH INSTABILITY OF AN MRH CONSTRUCT. DR. SUSPECTED INFECTION, BUT TEST RESULTS WERE NOT CONCLUSIVE GIVEN THE PATIENT¿S COMORBIDITIES. NO COMPLAINTS HAVE BEEN FILED AGAINST THE PREVIOUS IMPLANTS, NO FURTHER INFO AVAILABLE." SPOKE TO REP, WHO PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 12708483 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION ON (B)(6) 2020. PATIENT UNDERWENT PRIMARY TKA OUTSIDE OF CORS SCOPE. HAD A REVISION TKA FOR PJI ON (B)(6) 2018. WITH EXCHANGE OF POLYETHYLENE ONLY. THE PATIENT HAD RECURRENCE OF INFECTION AND HAD A REVISION TKA ON (B)(6) 2020. WHERE ALL COMPONENTS WERE EXCHANGE (PRE-CORS SCOPE AND POLY). THIS WAS REPORTED AS CORS PER 10467KNEE ((B)(6)). PATIENT HAD AGAIN RECURRENCE OF PJI AND UNDERWENT ANOTHER REVISION WHERE ALL THE HINGE COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 11370942 ↗
• InjuryFeb 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "NO TRAUMA TO PATIENT." TWO FEMORAL BUSHINGS AND AN INSERT WERE REVISED. UPDATE: "REVISED BECAUSE OF INFECTION. HOSPITAL AND SURGEON APPROACHED-NO FURTHER INFORMATION WILL BE PROVIDED. EXPLANTS DISPOSED BY HOSPITAL."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9708836 ↗
• InjuryJan 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE HAS BEEN REVISED DUE TO RECURRING INFECTION. AN ABOVE-KNEE AMPUTATION WAS PERFORMED, RETAINING ALL PROXIMAL FEMORAL COMPONENTS, AND IMPLANTING A CUSTOM PROSTHESIS CAP. USAGE SHEETS HAVE BEEN PROVIDED, AND THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9624202 ↗
• InjuryMay 21, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO WEAR OF THE POLY COMPONENT. POSSIBLE CAUSE OR CONTRIBUTOR FOR WEAR NOT REPORTED. PATIENT'S ACTIVITY LEVEL IS UNKNOWN. PATIENT WAS REVISED TO POLY COMPONENT OF THE SAME CATALOG NUMBER. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8627584 ↗
• InjuryMar 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT KNEE WAS REVISED. A NOTE AT THE BOTTOM OF THE SHEET REPORTS "REVISED FOR INSTABILITY AND POSSIBLE INFECTION". AN MRH KNEE CONSTRUCT WAS REVISED TO AN MRH/ GMRS KNEE CONSTRUCT.

  Patient problems: Ambulation or Postural Difficulties; Injury; Unspecified Infection

  MAUDE report 8436940 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT & PREVIOUS REVISION OUTSIDE OF CORS SCOPE. PATIENT HAD FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO PPFX, UNDERWENT THE REVISION OF TOTAL RIGHT KNEE WITH TREATMENT OF SUPRACONDYLAR FEMUR FRACTURE ON (B)(6) 2013 WITH A DFR BY DR. (B)(6). PATIENT HAD INFECTED PROSTHESIS RIGHT TOTAL KNEE REPLACEMENT AND SUBTOTAL SYNOVECTOMY EXCHANGED (B)(6) 2013. ALL COMPONENTS EXCHANGED EXCEPT FEMUR.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8362541 ↗