RECLAIM 2975-31-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10603295156369), received between Jun 28, 2017 and Apr 23, 2026 — classified as 90 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Material Deformation

  IT WAS REPORTED THAT NECK TRIAL AND STEM EXTRACTOR ARE STRIPPED OUT AND NEED REPLACED.ACTIVITY LEVEL - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971496 ↗
• 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 24183136 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878510 ↗
• MalfunctionAug 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE 40 MM TRIAL NECK SEGMENT FOR THE RECLAIM SET HAD A FAULTY STRIPPED LOCKING SCREW AND COULD NOT BE SUCCESSFULLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882926 ↗
• MalfunctionMar 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER 85MM BODY AND 40MM NECK HAD BEEN TORQUED TOGETHER, THE NECK STILL SPUN ON THE PROXIMAL BODY TRIAL. THIS MADE DISLOCATING THE HIP AFTER TRIALING DIFFICULT. THERE WAS 2 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630600 ↗
• MalfunctionFeb 10, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2025. WHEN LOOSENING A BOLT, IT SNAPPED, MAKING IT UNUSABLE. THREADING STRIPPED WHEN SCREWING IN. A 30MM DRILL BIT SNAPPED IN HALF. THE SURGICAL DELAY IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21346098 ↗
• MalfunctionJan 28, 2025Mechanical Jam; Mechanical Jam

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO DELAY AND NO CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 21256559 ↗
• MalfunctionJan 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 75 MM PROX TRIAL SHAFT AND 40MM NECK WAS NOT ENGAGING TO STEM. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159609 ↗
• MalfunctionJan 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 75 MM PROX TRIAL SHAFT AND 40MM NECK WAS NOT ENGAGING TO STEM. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159279 ↗
• MalfunctionDec 4, 2024Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information

  IT WAS REPORTED THAT THE 75MM PROXIMAL TRIAL SHAFT AND THE 40MM PROXIMAL NECK TRIAL IN THE RECLAIM SET WOULDN¿T LOCK DOWN AFTER TIGHTENING. IT WOULD SPIN WHEN THEY WOULD TRY TO REDUCE THE HIP.

  Patient problems: Insufficient Information

  MAUDE report 20846455 ↗
• MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT NECK AND BODY TRIALS WOULD NOT LOCK AND WOULD SPIN WHEN TRYING TO REDUCE THE HIP. THERE WAS NO DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689230 ↗
• MalfunctionJul 8, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: A. DID THE INSTRUMENT BREAK INTO 2 OR MORE PIECES? THE SCREW FELL OFF. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? WE TRIALED WITH THE 45MM NECK. NO ISSUE. C. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19688300 ↗
• MalfunctionJun 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENT WAS REPORTED FOR NOT FUNCTIONING PROPERLY. IT DID NOT HAPPEN IN SURGERY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457321 ↗
• MalfunctionMay 17, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE BOLT IN THE 40MM NECK TRIAL IS COLD WELDED CLOSED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19339956 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT THIS ITEM WAS BROKEN. IT WAS NOT POSSIBLE TO TEST THE FIT OF PROXIMAL BODY 75X20MM. AS A RESULT, THE VERSION REQUIRED FOR THE PROPER FUNCTIONING OF THE HIP COULD NOT BE TESTED AND THE VERSION MUST BE TESTED CORRECTLY IN ONE GO DIRECTLY WITH THE DEFINITIVE IMPLANT. THIS LEADS TO HAVING TO TAKE UNNECESSARILY HIGH RISKS WITH REGARD TO CORRECT IMPLANTATION. THERE IS A RISK OF IMPLANTING WITH THE WRONG/NON-OPTIMAL VERSION OF THE BODY. THIS ITEM HAS AN EXTREMELY CLEARLY VISIBLE HEX SCREW THAT MUST BE ABLE TO BE MANIPULATED.

  Patient problems: Insufficient Information

  MAUDE report 18920051 ↗
• MalfunctionDec 19, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT NOTICED INSTRUMENTS ARE BROKEN UPON INSPECTION: 254401003 - BROKEN/CRACKED PLASTIC. 254401006 - BROKEN/CRACKED PLASTIC . 297531040 - BOLT STUCK, OVER TIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356310 ↗
• MalfunctionOct 19, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SCREW THAT IS USED TO HOLD NECK TRIAL AGAINST THE PROXIMAL BODY TRIAL HAS FROZEN AND WILL NOT MOVE IN EITHER DIRECTION. NO PATIENT HARM CAME AS A RESULT OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965936 ↗
• MalfunctionOct 13, 2023Break; Break

  IT WAS REPORTED THAT THE RECLAIM TRIAL NECK BROKE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930816 ↗
• MalfunctionSep 15, 2023Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT PROXIMAL NECK TRIAL SCREW LOCKED. IT CANNOT UNLOCK. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757446 ↗
• MalfunctionJul 31, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE RECLAIM TRIAL NECK BROKE. AS THE SCREW WAS BEING TIGHTEN IT STRIPPED AND BROKE. NO PARTS WERE IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17426788 ↗
• MalfunctionMay 11, 2023Break; Break

  IT WAS REPORTED THAT THE SURGEON BROKE THE RING OFF THE NECK TRIAL WHILE TRYING TO TRIAL A HEAD. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913393 ↗
• 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 16550734 ↗
• MalfunctionFeb 27, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE NECK SEGMENT WOULD NOT SECURE TO THE STEM. THERE WAS A 5 MIN DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442835 ↗
• MalfunctionDec 9, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE NECK TRIAL WILL NOT LOOSEN WITH SCREWDRIVER. SCREW ON TRIAL IS STRIPPED. NO REPORTED SURGICAL DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950218 ↗
• MalfunctionDec 7, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT SCREW ON NECK TRIAL WOULD NOT TURN. SCREWDRIVER WAS STRIPPED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15934643 ↗