INSTRUMENT 1020-5206Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327252729), received between Jun 5, 2018 and Apr 14, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: ON MONDAY, (B)(6) 2026 DURING A TOTAL HIP REPLACEMENT SURGERY, A CURETTE FROM THE ACCOLADE STEM INSTRUMENT BROKE DURING THE PROCEDURE. THIS CURETTE IS USED TO PREPARE THE INTRAMEDULLARY CANAL PRIOR TO IMPLANTING THE ACCOLADE STEM AND IS ALSO LEFT IN PLACE AS A TRIAL STEM. DURING THE PROCEDURE, THE METAL SEGMENT WHERE THE EXTRACTOR IS INSERTED BROKE, PREVENTING ITS NORMAL REMOVAL FROM THE PATIENT. THE SURGEON HAD TO PERFORM A FEMORAL OSTEOTOMY TO REMOVE THE STEM, FOLLOWED BY A WIRE FIXATION, WHICH RESULTED IN A LONGER SURGICAL TIME AND AN ADDITIONAL, UNPLANNED PROCEDURE FOR THE PATIENT. THE PATIENT INDICATED THAT HE WILL BE TAKING LEGAL ACTION TO THE CLINIC AND WITH STRYKER. PROCEDURE IDENTIFICATION: LEFT HIP REPLACEMENT WITH TRIDENT1 ACETABULAR CUP AND ACCOLADE STEM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870190 ↗
• MalfunctionJul 31, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674583 ↗
• InjuryDec 20, 2023Fracture; Fracture

  BROKEN BROACH IN SITU. SURGEON NOTIFIED MPS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369778 ↗
• InjuryDec 15, 2023Fracture; Fracture

  DURING BROACHING FOR A THA USING THE ACCOLADE BROACHES, THE SURGEON REACHED THE DESIRED SIZE BROACH OF 6- WHEN ATTEMPTING TO REMOVE THE SIZE 6 BROACH FROM THE FEMORAL CANAL THE STUB ON TOP SNAPPED RESULTING IN THE BROACH BEING STUCK IN THE FEMORAL CANAL. THE SURGEON MADE ATTEMPTS TO REMOVE THE BROACH BUT ULTIMATELY HAD TO PERFORM AN ETO AND THEN USE DAL MILES CABLES AND CHANGED FEMORAL IMPLANT SYSTEM TO SECURFIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340883 ↗
• MalfunctionJun 5, 2023Fracture; Fracture

  IT WAS REPORTED, "WHEN HAMMERING IN THE HIP RASP, THE BASE OF THE HIP RASP BROKE OFF." ADDITIONAL INFORMATION: WHEN THE FEMORAL SHAFT WAS RASPED OPEN, THE CONNECTING PIN BETWEEN THE HANDLE AND THE RASP BROKE OFF. THE RASP COULD BE REMOVED FROM THE FEMUR WITHOUT ANY PROBLEMS, THE FRACTURE WAS ONLY NOTICED WHEN THE NEXT LARGER RASP WAS USED SHOULD BE INSERTED INTO THE HANDLE. AS PER SALES REP: "NO BONE FRACTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056890 ↗
• MalfunctionJun 5, 2018Break; Fracture; Delamination; Break; Fracture; Delamination

  COLOR MARKING FROM THE RASPS CRUMBLE OFF. REPLACEMENT WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7569334 ↗