STRIDE PFSR100931Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556627334), received between Nov 6, 2020 and Dec 22, 2021 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2021Break; Break

  IT WAS REPORTED THAT DURING A NAVIO ASSISTED UKR SURGERY, THE STRIDE FEMORAL INS/REM IMPACTOR HEAD WAS BEING USED INSIDE THE PATIENT WHEN A PIECE OF THE PLASTIC CRACKED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. AFTER THE SURGERY, THE STRIDE FEMORAL INS/REM IMPACTOR HEAD WAS FULLY BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060371 ↗
• InjuryAug 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED UKR SURGERY, THE STRIDE FEMORAL INS/REM IMPACTOR HEAD SPLIT IN HALF WHILE IMPACTING. NO DELAYS WERE REPORTED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342989 ↗
• InjuryMay 24, 2021Crack; Crack

  IT WAS REPORTED THAT, UPON IMPACTING THE FEMUR IN A NAVIO-ASSISTED UKR SURGERY, THE STRIDE FEMORAL INS/REM IMPACTOR HEAD CRACKED IN HALF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE (WRAPPED WITH COBAN) WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872967 ↗
• MalfunctionApr 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT, BEFORE A NAVIO UKR PROCEDURE, IT WAS FOUND THAT A STRIDE FEMORAL INSERTION/REMOVAL IMPACTOR HEAD WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. THERE WAS NO PATIENT AND NO DEBRIS INVOLVED AT THE MOMENT OF THE ISSUE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683778 ↗
• MalfunctionDec 15, 2020Crack; Crack

  IT WAS REPORTED THAT DURING AN INSTRUMENT TRAY REPROCESSING, IT WAS FOUND THAT THE STRIDE FEMORAL IMPACTOR WAS CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008941 ↗
• MalfunctionDec 15, 2020Crack; Crack

  IT WAS REPORTED THAT DURING AN INSTRUMENT TRAY REPROCESSING, IT WAS FOUND THAT THE STRIDE FEMORAL IMPACTOR WAS CRACKED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11008898 ↗
• MalfunctionNov 6, 2020Break; Break

  IT WAS REPORTED THAT THESE STRIDE FEMORAL INS/REM IMPACTOR HEAD ARE BROKEN. IT IS UNKNOWN WHERE THIS EVENT OCCURS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10804791 ↗
• MalfunctionNov 6, 2020Break; Break

  IT WAS REPORTED THAT THESE STRIDE FEMORAL INS/REM IMPACTOR HEAD ARE BROKEN. IT IS UNKNOWN WHERE THIS EVENT OCCURS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10804740 ↗