MRS 6485-3-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327049374), received between May 13, 2022 and May 13, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED HE HAD A LEFT KNEE TKA DONE ON 1999 AND WAS REVISED ON 2017 DUE TO PAIN AND ON 2019 (STRYKER IMPLANTS) DUE TO FUNGAL INFECTION. PATIENT IS UNSURE IF THE 1999 AND 2017 IMPLANTS ARE STRYKER. PATIENT STATED HIS PAIN NEVER WENT AWAY AND OVER THE LAST YEAR THE PAIN HAS BECOME EXTREME. HIS ROM HAS DECREASED TO 45 DEGREES AND HAS LEG DISCREPANCY, HIS LEFT LEG IS SHORTED THAN HIS RIGHT LEG. PATIENT IS ATTENDING PAIN MANAGEMENT. PATIENT WOULD LIKE TO KNOW IF HIS IMPLANTS ARE PART OF A RECALL. THE PATIENT WOULD LIKE ASSISTANCE WITH HIS REVISION AS THIS IS HIS FOURTH REVISION AND THERE'S A RISK OF AMPUTATION. THE PATIENT WOULD ALSO LIKE ASSISTANCE WITH WHO WILL BE THE BEST SURGEON TO GO TO AS HE DOES NOT WANT TO GET AMPUTATED.

  Patient problems: Fungal Infection; Loss of Range of Motion; Muscular Rigidity; Pain; Unequal Limb Length

  MAUDE report 14393179 ↗