MRH 6481-1-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327045154), received between Jul 20, 2018 and Aug 6, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Fracture” (8 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 12 most recent of 12 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 IIS 2023-001 INDICATES THE FOLLOWING: ARTHROFIBROSIS. NO COMPONENTS WERE REMOVED. LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22733062 ↗
• InjuryJan 6, 2025Degraded; Fracture; Detachment of Device or Device Component; Osseointegration Problem; Degraded; Fracture; Detachment of Device or Device Component; Osseointegration Problem

  STEM-GUIDED CTEP: FATIGUE OF THE FEMORAL COUPLING SITE BETWEEN THE STEM AND FEMORAL IMPLANT. SIGNIFICANT METALLOSIS IN THE JOINT, THE COUPLING POINT BETWEEN THE STEM AND THE FEMORAL COMPONENT IS CLEARLY LOOSENED. AXIAL DEVIATION AND ROTATIONAL INSTABILITY OF APPROX. 15 DEGREES THE FEMORAL COMPONENT CAN BE SALVAGED IN CONJUNCTION WITH THE STEM (OP ENDOGAP (B)(6) 2024). THE IMPLANT WAS TRANSFERRED TO THE PATIENT AT THE PATIENT'S REQUEST.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Metal Related Pathology

  MAUDE report 21080608 ↗
• InjuryMay 5, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PATIENT WAS REVISED DUE TO A FRACTURED DISTAL FEMUR AND THE FEMORAL COMPONENT STEM WAS DISASSOCIATED FROM THE BODY OF THE FEMORAL COMPONENT DUE TO IT BREAKING THROUGH THE THREADS OF THE STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 16874355 ↗
• InjurySep 14, 2022Fracture; Fracture

  THE FOLLOWING WAS REPORTED: TAPER FRACTURE BETWEEN FEMUR AND STEM.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15419128 ↗
• InjuryMay 26, 2022Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD A LEFT KNEE SURGERY WHERE STRYKER COMPONENTS WERE IMPLANTED ON (B)(6) 2019. PATIENT WAS REVISED ON (B)(6) 2020 FOR LOOSENING.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14506081 ↗
• InjuryMay 14, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PATIENT STATED HE HAD A LEFT KNEE SURGERY ON JAN 01, 2020 (APPRX) WITH STRYKER IMPLANTS AND WAS REVISED ON MAY 2021 DUE TO CRACKED IMPLANT. PATIENT STATED THIS IS HIS 7TH LEFT KNEE SURGERY BUT IS UNSURE IF PREVIOUS ONES ARE STRYKER IMPLANTS. PATIENT STATED THAT HE IS NOW EXPERIENCING HIS KNEE CAP GOING TO THE SIDE WHEN HE WALKS WHICH MAKES HIM WANT TO TRIP. PATIENT IS NOT SURE IF HIS 2021 IMPLANTS ARE STRYKER IMPLANTS. THIS REPORT IS FOR HIS 2021 REVISION DUE TO CRACKED IMPLANT.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14403144 ↗
• InjuryOct 13, 2020Break; Break

  IT WAS REPORTED VIA MEDWATCH REPORT MW5096317: "BROKEN PLATE."

  Patient problems: Insufficient Information

  MAUDE report 10669933 ↗
• InjurySep 15, 2020Fracture; Fracture

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. ORIGINAL PATIENT COMPLAINT WAS PAIN AND LIMB LENGTH DISCREPANCY. IT WAS FOUND INTRA-OPERATIVELY, THEN CONFIRMED IN A PRE-OPERATIVE X-RAY (AFTER THE PATIENT WAS OPENED) THAT THE LATERAL CONDYLE OF THE FEMORAL COMPONENT WAS BROKEN. PATIENT'S ENTIRE KNEE WAS CONVERTED TO A COMPETITOR CONSTRUCT.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain

  MAUDE report 10533716 ↗
• InjuryJul 10, 2020Fracture; Fracture

  AXLE BREAK.

  Patient problems: Ambulation or Postural Difficulties; No Known Impact Or Consequence To Patient

  MAUDE report 10257882 ↗
• InjuryJan 9, 2020Fracture; Fracture

  FRACTURE OF IMPLANTED MRH FEMORAL POSTERIOLATERAL METALL CONDYLE.

  Patient problems: Injury

  MAUDE report 9568181 ↗
• InjuryOct 16, 2018Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "PROCEDURE: THE PATIENT HAD A COMPLEX HISTORY REGARDING HIS LEFT KNEE. HAD AN INDEX TKA OUT OF CORS SCOPE, THEN HE HAD A NEUROLOGICAL DIAGNOSIS THAT LED TO INSTABILITY DUE TO HYPEREXTENSION. HE HAD LEFT KNEE REVISIONS ON (B)(6) 2017. ALL COMPONENTS EXCHANGED. NOW IT WAS NOTED THAT THE FEMORAL COMPONENT WAS LOOSE AND UNDERWENT SECOND LEFT KNEE REVISION ON (B)(6) 2018. LONGER STEM AND CONE EXCHANGED, PATELLAR COMPONENT RETAINED. SOME COMPONENTS IN THE SECOND REVISION ARE OFF-LABEL USE".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7971087 ↗
• InjuryJul 20, 2018Fracture; Fracture

  BROKEN MRH FEMUR COMPONENT (LEFT KNEE). REVISION SURGERY AND REPLACMENT OF THE BROKEN COMPONENT.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7707788 ↗