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Rheo Knee RKN130003Recalls & reported problems

Ossur Americas, Inc. · RHEO KNEE 3YRS WARRANTY · Class 1

All models of Rheo Knee (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
1

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05690967595418), received between Jun 25, 2018 and Jun 9, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Mar 25, 2024Class IIOpen, Classified

    Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

    Z-1788-2024 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Insufficient Device Problem Information1
  • Loose or Intermittent Connection1
  • Output Problem1

Patient problems

  • Fall5
  • Bone Fracture(s)2
  • Hip Fracture1
  • Rupture1
  • Unspecified Tissue Injury1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 9, 2022Output Problem

    PATIENT WAS STANDING IN A LADDER WHEN THE KNEE SUPPOSEDLY SHUT OFF CAUSING THE PATIENT TO FALL OFF THE LADDER AND BREAKING HIS HIP.

    Patient problems: Fall; Unspecified Tissue Injury

    MAUDE report 14643513 ↗
  • InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem

    THE PATIENT FELL AND BROKE HER ARM.

    Patient problems: Bone Fracture(s); Fall

    MAUDE report 8394294 ↗
  • InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem

    THE PATIENT FELL AND SUFFERED A RUPTURED PATELLA TENDON.

    Patient problems: Fall; Rupture

    MAUDE report 8288246 ↗
  • InjuryJan 29, 2019Insufficient Device Problem Information

    THE PATIENT FELL AND BROKE HIS RIBS.

    Patient problems: Bone Fracture(s); Fall

    MAUDE report 8284877 ↗
  • InjuryJun 25, 2018Loose or Intermittent Connection

    A WEEK OR TWO WEEKS INTO ORIGINAL KNEE, STARTED EXPERIENCING ISSUES, KNEE WAS SHUDDERING (NO OTHER ISSUES BESIDES SHUDDERING). SENT PRIMARY KNEE IN FOR SERVICING AND RECEIVED A LOANER KNEE. WHILE ON A LOANER KNEE HE FELL ((B)(6) 2018) AND BROKE HIS HIP, THE NEXT DAY (B)(6) 2018 RECEIVED SURGERY. HE WAS ON LOANER KNEE FROM (B)(6) 2017 UNTIL (B)(6) 2018. AFTER FALL HE WENT TO THE HOSPITAL; DIAGNOSED WITH FRACTURED HIP; RECEIVED MRI, CAT SCAN AND XRAYS, THAN EMERGENCY SURGERY NEXT MORNING. CURRENTLY NO MEDICATION IS BEING UTILIZED, HAS BEEN ATTENDING THERAPY TWICE A WEEK AND HAS ALREADY COMPLETED FOR A WHOLE MONTH.

    Patient problems: Fall; Hip Fracture

    MAUDE report 7634307 ↗

Other Joint, Knee, External Limb Component devices

All Joint, Knee, External Limb Component devices →

Sources and updates

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