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STRIDE PFSR101002Recalls & reported problems

Smith & Nephew, Inc. · Stride Insert Trial Size C 8mm · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556627723), received between Apr 21, 2020 and Apr 22, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 22, 2020Break; Break

    IT WAS REPORTED THAT ITEM BROKE DURING SURGERY. THERE WAS A BACK-UP DEVICE AVAILABLE AND THE PROCEDURE WAS COMPLETED WITH NO DELAYS. IT IS UNKNOWN IF THERE WAS IMPACT TO THE PATIENT DUE TO THIS ISSUE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9986811 ↗
  • InjuryApr 21, 2020Break; Break

    IT WAS REPORTED THAT DURING A CASE TODAY WE HAD AN ISSUE WITH TRIALLING THE POLYS. SURGEON SLID IN THE TRIAL POLY AND EACH TIME HE DID SO, IT SEEMED TO ROCK BACK AND FORTH ANTERIOR TO POSTERIOR INSIDE THE TIBIAL TRAY. THIS CAUSED ISSUES TRIALLING OUR FINAL ROM, ESPECIALLY WHEN HE TRIED TO BRING THE LEG INTO FULL EXTENSION WHERE THE POLY WAS PUSHED TO THE POSTERIOR EACH TIME. THE SURGEON KEPT PLAYING WITH POLY TRIALS UNTIL THEY WERE ABLE TO PROPERLY ASSESS THE FIT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9983817 ↗

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.