INSTRUMENT 6260-4-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327217896), received between Oct 15, 2018 and Nov 6, 2025 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Fracture; Fracture

  WHEN USED IN CONJUNCTION WITH A SLIDE HAMMER TO REMOVE THE IMPLANT (FEMORAL COMPONENTS AND STEMS), THE TIP'S THREADS OF [6266-0-120] SNAPPED OFF WHILE STILL EMBEDDED IN THE IMPLANT [64951201]. THE BROKEN FRAGMENT REMAINED STUCK INSIDE THE IMPLANT [64951201] AND WAS REMOVED ALONG WITH THE IMPLANT. IMPLANT REMOVAL WAS REPORTED IN PI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486956 ↗
• MalfunctionDec 23, 2024Fracture; Fracture

  AS REPORTED VIA MEDWATCH MW5161519: STRYKER THREADED STEM EXTRACTOR BROKE INTO 2 PIECES DURING USE. PER SURGEON THE THREADED PORTION WAS UNABLE TO BE RETRIEVED FROM THE FEMORAL STEM. BROKEN PORTION OF INSTRUMENT REMAINED IN PATIENTS FEMORAL IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21006833 ↗
• MalfunctionOct 30, 2024Fracture; Fracture

  MCREYNOLDS TIP SNAPPED WHEN TRYING TO EXTRACT THE STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570272 ↗
• MalfunctionOct 28, 2024Damaged Thread; Damaged Thread

  DURING REVISION WHILE ATTEMPTING TO REMOVE THE RESTORATION MODULAR STEM, THE MCREYNOLDS ADAPTOR SHEARED OFF AT THE THREADS. SURGEON DECIDED TO USE A BRAND NEW PROXIMAL BODY WITHOUT A SCREW TO AVOID PERFORMING A FULL OSTEOTOMY ALTHOUGH REP MENTIONED THIS WAS OFF-LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553402 ↗
• InjuryFeb 27, 2024Fracture; Fracture

  AS DESCRIBED BY REPORTING PARTY: "DURING THE SURGICAL PROCEDURE THE INSTRUMENT BROKE." "FAILURE TO REMOVE THE IMPLANT AND CHANGE OF PLANNED PROCEDURE."

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

  MAUDE report 18786810 ↗
• MalfunctionAug 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION OF THE PATIENT'S RIGHT HIP, THE MCREYNOLDS ADAPTER BROKE OFF WHILE EXTRACTING AN ACCOLADE II STEM. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

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

  MAUDE report 15137408 ↗
• InjuryJul 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT AS A RESULT OF THE BREAKAGE OF THE MCREYNOLDS ADAPTOR, THE SURGEON HAD TO PERFORM AN EXTENDED TROCHANTERIC OSTEOTOMY TO REMOVE THE STEM.

  Patient problems: Insufficient Information

  MAUDE report 14988939 ↗
• MalfunctionMay 4, 2022Fracture; Fracture

  THE RESTORATION MODULAR EXTRACTION DEVICE BROKE WITH THE STEM IN THE CANAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274951 ↗
• MalfunctionNov 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION OF THE PATIENT'S LEFT HIP, THE THREADED PORTION OF THE MCREYNOLDS ADAPTOR BROKE OFF DURING DISIMPACTION. PATIENT WAS VISUALLY INSPECTED TO ENSURE THAT NO PIECES REMAINED IN THE PATIENT. THE RESTORATION MODULAR PROXIMAL BODY WAS REMOVED, AND A SPACER WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860362 ↗
• MalfunctionJul 9, 2021Fracture; Fracture

  MCREYNOLDS ADAPTOR TOOL BROKE INSIDE THE STEM WHILE TRYING TO REMOVE THE INFECTED IMPLANT. LEFT THA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12141301 ↗
• MalfunctionFeb 18, 2021Fracture; Fracture

  AS REPORTED: "STEM EXTRACTION DEVICE BROKE DURING PROCEDURE. SLIGHT DELAY (APPROXIMATELY 2 MINUTES) IN CASE AS WE NEEDED TO OPEN A SECOND EXTRACTION DEVICE. IT WAS JUST OUTSIDE THE OR." PROCEDURE WAS A LEFT HIP REVISION. SPOKE TO REP, WHO PROVIDED A DEVICE PICTURE AND REPORTED HE MAY BE ABLE TO RETURN THE DEVICE, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11341959 ↗
• MalfunctionDec 18, 2020Fracture; Fracture

  BROKEN MCREYNOLDS STEM ADAPTER. DEVICE BROKE WHILE TRYING TO REMOVE A STRYKER STEM DURING A REVISION SURGERY. AS THE BROKEN PORTION OF THE INSTRUMENT AND THE IMPLANTED STEM WOULD HAVE REQUIRED AN EXTENDED TROCHANTERIC OSTEOTOMY, THE SURGEON ELECTED TO INSTEAD LEAVE THE STEM IN SITU AND IMPLANTED A FEMORAL HEAD WITH A GREATER OFFSET. REP CONFIRMED THERE WAS NO SURGICAL DELAY, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL, OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11035869 ↗
• MalfunctionDec 12, 2020Fracture; No Device Output; Adverse Event Without Identified Device or Use Problem; Fracture; No Device Output; Adverse Event Without Identified Device or Use Problem

  STRYKER REP REPORTED THAT NIGHT DURING A HIP REVISION, THE SURGEON ATTEMPTED TO REMOVE A CONICAL DISTAL STEM (RESTORATION CONE CONICAL) AFTER INITIAL IMPACTION THE STEM WAS SITTING TO PROUD AND HE WANTED TO DOWNSIZE THE STEM FROM A 19MM X 155 TO AN 18 X 155. THE SURGEON APPLIED THE STEM EXTRACTION BOLT TO THE THREADED FEMALE END OF THE STEM AND ATTACHED THE SLAP HAMMER WHILE SLAP HAMMERING THE STEM OUT THE BOLT SNAPPED INSIDE THE CONICAL STEM BUT THAT IT COULDN¿T BE REMOVED AS THE STEM WAS WELL FIXED. THE SURGEON HAD TO SPEND A SIGNIFICANT AMOUNT OF TIME REMOVING THE STEM EVENTUALLY BY USING HIGH SPEED CUTTING DEVICE TO CREATE A RIDGE IN THE STEM TO REMOVE IT IN A LINEAR FASHION. HE HAD TO PERFORM 3 PRESSURE RELIEF OSTEOTOMIES TO HELP REMOVE THE STEM. THE CASE WAS COMPLETED FOLLOWING REMOVAL OF THE STEM WITH 155 X 18 STEM INSERTED. *UPDATE: REP REPORTED THAT "NO STRYKER IMPLANT WAS BEING REVISED WE WERE ATTEMPTING TO REMOVE THE STEM WE HAD JUST SEATED TO REAM ONCE MORE AND SINK SLIGHTLY FURTHER DISTAL FOLLOWING UNSATISFACTORY TRIAL REDUCTION WITH STD CONE BODY"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10996128 ↗
• MalfunctionNov 27, 2020Fracture; Fracture

  MCREYNOLDS ADAPTOR WAS SCREWED INTO STEM AND BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10913162 ↗
• MalfunctionNov 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A REVISION OF THE PATIENT'S RIGHT HIP, THE DISTAL THREADED PORTION OF THE MCREYNOLDS EXTRACTOR BROKE INSIDE THE IMPLANT. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO SURGICAL DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10808275 ↗
• MalfunctionOct 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT WHEN TRYING TO REMOVE AN ACCOLADE STEM FROM THE PATIENT'S LEFT FEMUR THE THREADED PORTION OF THE MCREYNOLDS ADAPTER BROKE OFF. REVISION WAS PERFORMED SUCCESSFULLY WITH NO DELAY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10696725 ↗
• MalfunctionSep 2, 2020Fracture; Fracture

  INSTRUMENT IS INSPECTED AFTER CLEANING AND THE FAULT IS DISCOVERED AT STERIL CENTRALEN. IT WAS NOT DISCOVERED DURING THE OPERATION AND NO REPLACEMENT WAS USED. INSTRUMENT RETURNED FOR EXAMINATION. THE TIP/THREADS AT THE END WAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10483667 ↗
• MalfunctionJun 30, 2020Break; Break

  DURING A REVISION OF A COMPETITOR HIP, THE MCREYNOLDS ADAPTER WAS FOUND TO HAVE A BROKEN THREADED PORTION. DISCOVERY WAS MADE BEFORE IT WAS GOING TO BE USED. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY. REP CONFIRMED THE DEVICE IS ALLEGEDLY AVAILABLE FOR RETURN, AND OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10210830 ↗
• MalfunctionJan 9, 2020Fracture; Fracture

  WAS USING THE MCREYNOLDS ADAPTOR TO REMOVE AN ACCOLADE 2 STEM AND THE TIP OF THE THREADS BROKE OFF IN THE STEM. WHEN THE ADAPTOR RESALES ED FROM THE STEM THE TIP WAS MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9569446 ↗
• MalfunctionMar 27, 2019Crack; Fracture; Misassembled; Crack; Fracture; Misassembled

  WHILE PERFORMING A REVISION OF PATIENT'S HIP, THE IMPACTOR ADAPTER WASN'T FULLY SCREWED INTO THE STEM. WHEN THE INSTRUMENT WAS BACK SLAPPED, THE THREADS SHEARED OFF IN THE STEM. ANOTHER DEVICE WAS IMMEDIATELY AVAILABLE AND REMOVAL WAS COMPLETED WITH NO SURGICAL DELAY. REP REPORTED THAT THE SURGEON AND HOSPITAL HAVE NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457823 ↗
• MalfunctionJan 4, 2019Material Deformation; Material Deformation

  WHILE CHECKING INSTRUMENTS FOUND DAMAGED THREADS ON STEM REMOVAL ADAPTER AT WAREHOUSE.

  Patient problems: No Patient Involvement

  MAUDE report 8219565 ↗
• MalfunctionDec 12, 2018Break; Break

  THE SURGEON USED THE MCREYNOLD'S ADAPTER TO REMOVE AND REINSERT THE RESTORATION MODULAR STEM. IT WORKED SUCCESSFULLY, BUT HE REALIZED THE THREADS WERE DAMAGED. HE REQUESTING IT BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8157766 ↗
• MalfunctionOct 29, 2018Crack; Fracture; Crack; Fracture

  THIS PI IS FOR THE INTRA-OP EVENT ON (B)(6) 2018. DURING A REVISION OF PATIENT'S LEFT HIP, THE SCREW PIECE OF THE MCREYNOLDS IMPACTOR ADAPTER SNAPPED OFF THE DEVICE. NO PIECES WERE LEFT IN THE PATIENT. CASE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8017353 ↗
• MalfunctionOct 15, 2018Crack; Fracture; Crack; Fracture

  DR. (B)(6) WAS DOING A RESTORATION MODULAR WHEN HE NEEDED TO USE THE MCREYNOLDS ADAPTER AND THE TIP OF IT BROKE OFF. HE THEN USED A POLY REMOVAL TOOL TO EXTRACT A ZIMMER POLY WHEN IT ENDED UP WORKING BUT IT DID GET BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7965796 ↗