RECLAIM 2975-31-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10603295156376), received between Jul 7, 2017 and Jan 26, 2026 — classified as 80 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Material Deformation

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE RECLAIM MODULAR INSTRUMENTS WERE STRIPPED OUT AND NON-FUNCTIONAL. THE SURGEON HAD TO TRIAL OFF REAL IMPLANTS. THERE WAS NO PATIENT HARM, BUT THE PROCEDURE WAS DELAYED BY NINETY MINUTES DUE TO THE INABILITY TO PROPERLY TRIAL AND STRUGGLE WITH THE INSTRUMENTS. ACTIVITY LEVEL ¿ YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183182 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE RECLAIM NECKS USE DURING HIP REVISION ARE DAMAGE AND BEYOND USE. THE HEX HEAD LOCKING SCREW BECOMES FULLY EXTENDED AND LOCKS OUT. RESULTING THE SCREWDRIVER TORQUE LIMITATION. UNABLE TO LOCK DOWN THE TRIAL POSTS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF OTHER, DEVICE IN POSSESSION OF NONE, (B)(4), DEVICE PROPERTY OF OTHER, DEVICE IN POSSESSION OF 1. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878565 ↗
• MalfunctionSep 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS DOING A HIP REVISION, REMOVAL OF ANOTHER COMPANIES STEM AND WHEN WE WERE TRIALING THE RECLAIM SEGMENTS, THE TRIAL 95MM POST AND THE 45 NECK TRAIL WAS NOT LOCKING TIGHTLY WHICH WAS ALLOWING THE NECK TRIAL TO MOVE WHILE TRIALING THE HIP. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076020 ↗
• MalfunctionSep 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS DOING A HIP REVISION, REMOVAL OF ANOTHER COMPANIES STEM AND WHEN WE WERE TRIALING THE RECLAIM SEGMENTS, THE TRIAL 95MM POST AND THE 45 NECK TRAIL WAS NOT LOCKING TIGHTLY WHICH WAS ALLOWING THE NECK TRIAL TO MOVE WHILE TRIALING THE HIP. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075914 ↗
• MalfunctionJul 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CASE WAS NOT EFFECTED BUT THE 45 NECK TRIAL SEIZED UP AND COULD NOT BE LOOSENED OFF OF THE PROXIMAL TRIAL SHAFT. THE INTERNAL SCREW WAS JUST TORQUE LIMIT CLICKING IN BOTH DIRECTIONS. AFTER CASE HAD IT SOAKED AND LUBRICATED BUT STILL UNABLE TO GET THE NECK TO FULLY LOOSEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385439 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THE RECLAIM NECK TRIAL SCREW BROKE OFF. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236202 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT RECLAIM PROXIMAL BODY TRIAL SHAFT AND NECK WOULD SPIN WHEN SURGEON TRIED TO REDUCE THE HIP. THEY APPEARED TO BE WORN AND WOULD NOT STAY LOCKED. THERE WERE NO OTHER COMPLAINTS AND NO HARM TO PATIENT AND NO DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062095 ↗
• MalfunctionMar 5, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE RECLAIM MODULAR 45 PROXIMAL BODY TRIAL WAS JAMMED UP/BROKEN. THERE WAS NO SURGICAL DELAY AND NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529660 ↗
• MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689104 ↗
• MalfunctionOct 28, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BOLTS NO LONGER SCREW ON AND TIGHTEN DOWN.

  Patient problems: Insufficient Information

  MAUDE report 20543860 ↗
• MalfunctionOct 28, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE BOLTS NO LONGER SCREW ON AND TIGHTEN DOWN.

  Patient problems: Insufficient Information

  MAUDE report 20543783 ↗
• MalfunctionSep 4, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE LOCKING SCREW IS GETTING STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134835 ↗
• MalfunctionJun 7, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE METAL RING AROUND 45MM NECK TRIAL WAS BENT AND HAD TO BE REMOVED. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19483093 ↗
• MalfunctionJun 6, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE RECLAIM 45MM NECK TRIAL HAS A LOOSE METAL RING AROUND THE TOP OF THE NECK, PREVENTING A HEAD-BALL TRIAL FROM FITTING PROPERLY. SURGERY TIME WAS NOT EXTENDED. NO PIECES WERE DISLODGED FROM THE INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 19475177 ↗
• MalfunctionMay 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SCREW WAS COLD WELDED ON THE 45MM TRIAL NECK SEGMENT. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19319902 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RETAINING CLIP WAS DEFECTIVE AND FELL OFF. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139873 ↗
• MalfunctionSep 5, 2023Break; Break

  IT WAS REPORTED THAT NECK TRIAL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684874 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT THE NECK TRIAL BOLT HEAD BROKE WHEN TRYING TO SEAT THE NECK, THE PIECES WHERE ALL RETREATED AND TRIALED WITH THE OTHER NECK TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17023102 ↗
• MalfunctionMay 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 45MM NECK TRIAL WOULD NOT UNSCREW MAKING IT UNABLE TO USE. AFTER THE CASE, SURGEON TRIED TO FIX THIS ISSUE, BUT WITHOUT ANY SUCCESS. THIS DID HAPPEN DURING SURGERY, IT CAUSED A SLIGHT DELAY AS WE WERE TRYING TO FIX THE ISSUE. THE DELAY OR ISSUE WITH THE INSTRUMENT DID NOT CAUSE ANY ISSUES FOR THE PATIENT OR WITH THEIR RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984254 ↗
• MalfunctionMar 15, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE RECLAIM NECK TRIALS WERE NOT STAYING IN POSITION WHEN SURGEON WAS DOING FINAL TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550702 ↗
• MalfunctionFeb 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATED THAT THE TRIAL NECK WAS SPINNING ON THE TRIAL PROXIMAL BODY DURING TRIALING. THIS CAUSED SIGNIFICANT FRUSTRATION, LACK OF BEING ABLE TO TRIAL PROPERLY, 2 WASTED IMPLANTS BY DEPUY AND 1 WASTED IMPLANT BY OTHER COMPANY. OTHER COMPANY'S CUP WAS BEING USED FOR THIS REVISION. NO PIECES WERE BROKEN, ALL PIECES WERE RECOVERED AND PATIENT DID NOT SUFFER ANY KNOWN ADVERSE EFFECTS AS A RESULT. THERE WAS A 150MIN OF SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403388 ↗
• MalfunctionDec 14, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ITEMS WILL NOT THREAD, SURGEON COMPLAIN ABOUT THREADS STRIPPING ON ALL ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983828 ↗
• MalfunctionOct 20, 2022Break; Break

  IT WAS REPORTED THAT THE PIN IN THE HEAD OF THE SLAP HAMMER WHERE IT IS HIT HAS COME OUT, THE THREADS FOR THE NECK HAVE GONE FOR THE 45 NECK TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638126 ↗
• MalfunctionAug 9, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ALL INSTRUMENTS FOUND STRIPPED IN CENTRAL STERILE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190932 ↗
• MalfunctionJun 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE NECK SEGMENT WOULD NOT TIGHTEN. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852499 ↗