NA 2598-07-570Recalls & reported problems

Summary

The FDA's MAUDE database contains 505 adverse event reports that list this exact device (DI 10603295148548), received between Jun 28, 2017 and Sep 10, 2026 — classified as 5 injuries, 500 malfunctions.

The most frequently reported specific device problem is “Break” (174 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 505 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722335 ↗
• MalfunctionSep 10, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722183 ↗
• MalfunctionAug 6, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159575 ↗
• MalfunctionJun 17, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE HANDLE GOT DAMAGED AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537158 ↗
• MalfunctionJun 2, 2026Material Deformation

  IT WAS REPORTED THAT DURING HIP SURGERY THE THREADS ON THE INSERTER WERE DAMAGED AND NO LONGER WORKED. THERE WAS NO DELAY IN THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363443 ↗
• MalfunctionMay 29, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT WHEN THE SURGEON WAS EXPLANTING A DEPUY STEM AND CROSS-THREADED STEM EXTRACTOR INTO THE HOSPITAL'S SLAP HAMMER, IT WAS OBSERVED THAT THE INSTRUMENT COULD NOT BE SEPARATED FROM THE SLAP HAMMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331175 ↗
• MalfunctionMay 5, 2026Crack

  IT WAS REPORTED THAT THE THREADED INSERT TIP WAS CRACKED WHEN INSERTING STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082581 ↗
• MalfunctionApr 27, 2026Material Deformation

  IT WAS REPORTED THAT THE RETAINING STEM INSERTER DEVICE HAD STRIPPED THREADS. THERE WAS NO PATIENT CONSEQUENCES. ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008054 ↗
• MalfunctionApr 17, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE STEM INSERTER HANDLE IS CROSS THREADED AND REQUIRED REPLACEMENT. THEY USED A SINGLE PIECE STEM INSERTER. THERE WAS NO DELAY TO THE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910221 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIP OF THE RETAINING STEM INSERTER DEVICE BROKE OFF. IT WAS REPORTED THAT THE PROCEDURE WAS CONTINUED WITH ANOTHER LIKE DEVICE. THERE WAS NO DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791284 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THREADED INSERTER HAD BECOME LODGED ONTO STEM AND COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756062 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT THE THREAD SNAPPED DURING USE. ANOTHER DEVICE WAS OPENED. THERE WERE NO CONSEQUENCES TO THE PATIENT DUE TO COMPLAINT. THE SURGERY WAS NOT PROLONGED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698418 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT THE DEVICE IS BROKEN DURING STEM EXTRACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536290 ↗
• MalfunctionMar 5, 2026Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT THE CORAIL INSERTER BECOME STUCK TOGETHER DURING USE. THREADS BECAME LOCKED POSSIBLY CROSS THREADED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523790 ↗
• MalfunctionMar 5, 2026Device-Device Incompatibility; Material Deformation; No Apparent Adverse Event

  IT WAS REPORTED THE INTERNAL THREADING APPEARS TO HAVE BEEN COMPROMISED. WE ARE CURRENTLY UNABLE TO USE THE INSTRUMENT AS IT JAMS CONSISTENTLY WHEN ATTEMPTING TO ENGAGE A STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521067 ↗
• MalfunctionMar 5, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THE INTERNAL THREADING APPEARS TO HAVE BEEN COMPROMISED. WE ARE CURRENTLY UNABLE TO USE THE INSTRUMENT AS IT JAMS CONSISTENTLY WHEN ATTEMPTING TO ENGAGE A STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521007 ↗
• MalfunctionMar 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER USING THE THREADED STEM EXTRACTOR WE WERE UNABLE TO TAKE THEM APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520206 ↗
• MalfunctionMar 4, 2026Material Deformation

  IT WAS REPORTED THAT THE THREADS ON THE SUMMIT THREADED INSERTER BROKE. SURGEON REQUESTED A NEW ONE. THERE WAS NO EXTRA TIME AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513973 ↗
• MalfunctionFeb 24, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW IN THE INSERTER WAS NOT SCREWING IN. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434122 ↗
• MalfunctionFeb 19, 2026Break

  ADDITIONAL INFORMATION RECEIVED. THE ADDITIONAL INFORMATION RECEIVED DID NOT ESTABLISH WHETHER IT WAS THE SAME DEVICES THAT WERE INVOLVED FOR BOTH EVENTS OR IF DIFFERENT DEVICES WERE INVOLVED WITH THE EVENT THAT OCCURRED ¿15 DAYS PRIOR¿. CAN YOU KINDLY CONFIRM IF BOTH THESE DEVICES WERE USED IN BOTH EVENTS? THE ANSWER IS YES, IN BOTH PROCEDURES THE SAME INSTRUMENTAL WAS ADDED (THE SAME PIECES REPORTED) BOTH IN THE (B)(6) SURGERY AND IN THE ONE THAT HAD BEEN PERFORMED 15 DAYS BEFORE ((B)(6), IN WHICH, IS SUPPORT, OMITTED TO REPORT THE DAMAGED LEGS, THEREFORE, THEY ARE ASSIGNED FOR THE (B)(6) SURGERY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391106 ↗
• MalfunctionFeb 16, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE HIP, WHILE MOUNTING THE DRILL BIT ON THE FLEXIBLE HANDLE TO DRILL THE CUP HOLES, IT CAME LOOSE. IT WAS REPORTED THAT SEVERAL ATTEMPTS WERE MADE TO MOUNT IT, BUT IT WOULD NOT STAY IN PLACE, AND THE SURGEON WAS UNABLE TO DRILL TO FIX THE ACETABULAR CUP. THE PHYSICIAN STATED THAT THIS EVENT HAD HAPPENED 15 DAYS PRIOR DURING THE PREVIOUS SURGERY, WHICH HE HAD REPORTED TO THE SUPPORT STAFF ASSISTING WITH THE PROCEDURE. AS A SOLUTION, THE REPORTER REQUESTED THAT THE EQUIPMENT FOR THE NEXT PATIENT BE PROVIDED TO CONTINUE THE PROCEDURE AND PROCEED WITH THE SURGERY. WHEN THE FINAL STEM WAS HANDED TO ME, THE REPORTER PICKED UP THE IMPACTOR AND NOTICED THAT PART OF THE DISTAL PORTION WAS MISSING. MOUNTING WAS ATTEMPTED, BUT THE THREADS DID NOT ENGAGE TO SECURE THE IMPLANT. THE DOCTOR REALIZED THE PROBLEM AGAIN AND STATED THAT THE SAME THING HAD HAPPENED IN THE PREVIOUS SURGERY, AND THE SUPPORT STAFF WAS AWARE OF IT. IT WAS REPORTED THAT SPARE PARTS WERE AVAILABLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THERE WAS A SLIGHT DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344268 ↗
• MalfunctionFeb 3, 2026Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS CROSS THREADED. THIS EVENT DID NOT HAPPEN IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252459 ↗
• MalfunctionFeb 3, 2026Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS CROSS THREADED. THIS EVENT DID NOT HAPPEN IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252446 ↗
• MalfunctionFeb 3, 2026Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS CROSS THREADED. THIS EVENT DID NOT HAPPEN IN THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252443 ↗
• MalfunctionJan 9, 2026Material Deformation

  IT WAS REPORTED THAT THE SUMMIT SCREW IN INSERTER WAS CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019720 ↗