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STRIDE PFSR101006Recalls & reported problems

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556627761), received between Apr 21, 2020 and Apr 21, 2020 — classified as 1 injury.

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

Most reported problems

Device problems

  • Break1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjuryApr 21, 2020Break; Break

    IT WAS REPORTED THAT INSERT TRIAL BROKE DURING TRIALING. IT IS UNKNOWN IF PIECES NEEDED TO BE RETRIEVED FROM THE PATIENT OR NOT. BUT NO PATIENT INJURY WAS REPORTED.

    Patient problems: Injury

    MAUDE report 9984062 ↗

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.