MRH 6481-3-220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327043839), received between Jun 25, 2019 and Oct 28, 2025 — classified as 5 injuries.

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

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

• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE. PATIENT REVISED DUE TO INFECTION. REPLACED WITH A STATIC NAIL SPACER. NO OTHER INFORMATION AVAILABLE DUE TO THE HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 23403728 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 21592763 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT RIGHT INDEX TKA OUTSIDE CORS SCOPE. ON (B)(6) 2021 PATIENT PRESENTS WITH PAIN AND IS STUDIED FOR INFECTION. SHE IS REVISED FOR PJI ON (B)(6) 2021. LINER AND ALL ROTATING COMPONENTS WERE EXCHANGED. PATIENT PERSISTS WITH INFECTION AND UNDERGOES REVISION OF RIGHT KNEE FOR PJI ON (B)(6) 2021. ALL COMPONENTS ARE EXCHANGED.

  MAUDE report 13765620 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT RIGHT INDEX TKA OUTSIDE CORS SCOPE. ON (B)(6) 2021 PATIENT PRESENTS WITH PAIN AND IS STUDIED FOR INFECTION. SHE IS REVISED FOR PJI ON (B)(6) 2021. LINER AND ALL ROTATING COMPONENTS WERE EXCHANGED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13732803 ↗
• InjuryJun 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT KNEE REVISION DUE TO POSSIBLE INFECTION. THE SURGEON DID NOT CONFIRM WHETHER OR NOT THIS WAS THE CASE AT THE TIME OF SURGERY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8730473 ↗