RECLAIM 2975-29-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10603295156260), received between Nov 9, 2017 and Jan 26, 2026 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 38 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 24183241 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE ROD LOCATED INSIDE THE INSTRUMENT WAS BROKEN WHEN TIGHTENING THE SCREW ON TOP. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377642 ↗
• MalfunctionJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BOLT AND SCREW CAME OUT OF PROX TRIAL BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175443 ↗
• 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 22062089 ↗
• 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 21159359 ↗
• 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 21159306 ↗
• 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 20847506 ↗
• MalfunctionJul 24, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED: - DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY, IS IT DULL, BENT, CRACKED, STRIPPED, SCRATCHED, WORN, SCRATCHED, CROSS-THREADED, OR ANY DEVICE INTERACTION ISSUES? YES. THE INNER SCREW CAME OUT. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818065 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN DURING USE . THIS DID NOT CAUSE ANY HARM TO THE PATIENT NOR SIGNIFICANT DELAYS. ALL BROKEN PIECES WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650736 ↗
• MalfunctionFeb 13, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT AFTER IMPACTING THE DISTAL RECLAIM STEM IMPLANT, DOCTOR WENT TO TRIAL THE 75MM PROXIMAL TRIAL SHAFT. AFTER ATTACHING THE TRIAL NECK AND TIGHTENING THE NUT, DOCTOR WENT TO REDUCE AND TRIAL THE CONSTRUCT AND THE NECK WOULD SPIN FREELY ON THE PROXIMAL TRIAL SHAFT. UNABLE TO ACHIEVE DESIRED VERSION THEY INSPECTED THE TRIAL SHAFT AND SAW THAT THE THREADS ON THE SHAFT WERE STRIPPED AND DAMAGED. THEY THEN BEGAN TO TRIAL WITH THE 85MM TRIAL SHAFT AND RAN INTO THE SAME ISSUE, WITH THE THREADS UNABLE TO FULLY ENGAGE THE TRIAL NECK. HE THEN MARKED HIS DESIRED VERSION, AND WE OPENED THE PROXIMAL BODY IMPLANT AND IMPLANTED. THERE WAS NO DIRECT DELAY TO THE CASE, THERE WERE NO MISSING PARTS FROM THE IMPLANT AND NO HARM WAS DONE TO THE PATIENT. NO FURTHER INFORMATION ON THIS SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699513 ↗
• MalfunctionJul 24, 2023Break; Break

  IT WAS REPORTED THAT THE ITEM WAS BROKEN WHILE USING DURING A TOTAL HIP REVISION CASE. THIS DID NOT CAUSE ANY HARM TO THE PATIENT OR DELAYS TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379741 ↗
• MalfunctionJun 29, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE RECLAIM NECK TRIALS WERE NOT STAYING IN POSITION WHEN SURGEON WAS DOING FINAL TRAILING. THERE WAS NO DELAY IN PROCEDURE AND ALL DAMAGED TRIALS WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231803 ↗
• 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 16550732 ↗
• MalfunctionFeb 21, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT DURING TRIALING, THE NECK SEGMENT WAS SPINNING ON THE TRIAL PROXIMAL BODY. TRIAL PROXIMAL BODY SEEM TO BE STRIPPED. NOTHING APPEARS TO BE BROKEN. NO ADVERSE SIDE AFFECTS TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410481 ↗
• 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 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403317 ↗
• MalfunctionOct 7, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE TRIAL SPINS ON PROXIMAL BODY DUE TO LOSS OF CONSTRAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15558765 ↗
• 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 15190938 ↗
• MalfunctionMar 8, 2022Naturally Worn; Naturally Worn

  THE GROOVES ARE WORN DOWN CAUSING NECK TRIAL TO SPIN ON THE BODY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13697218 ↗
• MalfunctionFeb 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT AS "THREADED PART OF THE BODY IS BENT AND WON¿T ENGAGE WITH DISTAL STEM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13415844 ↗
• MalfunctionSep 29, 2021Break; Break

  IT WAS REPORTED THAT UPON TRIALING THE 75 BODY, THE SCREW THAT ATTACHES TO THE STEM BROKE INTO THREE PIECES. ALL OF THOSE PIECES WERE RETRIEVED. ROUGHLY 2 MINUTES OF ADDITIONAL TIME WAS REQUIRED TO SECURE THE BROKEN TRIAL BODY.

  Patient problems: Insufficient Information

  MAUDE report 12547697 ↗
• MalfunctionSep 15, 2021Naturally Worn; Naturally Worn

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT THE RECLAIM BODY IS STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475787 ↗
• InjuryAug 4, 2021Break; Break

  IT WAS ALSO REPORTED THAT DUE TO A BROKEN TEST COMPONENT INSIDE THE INSTRUMENTS, DISLOCATION PROBLEMS OCCURRED AT THE END OF THE SURGERY. FACED WITH THIS PROBLEM, THE SURGEON DECIDED TO REPLACE THE HEAD AND INSERT.

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273755 ↗
• MalfunctionJan 14, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NECK TRIAL AND THE PROXIMAL BODIES WERE STRIPPED DURING NORMAL USE. THE T-HANDLE HEX SCREW DRIVER WAS TORQUED- LIMITING IN REVERSE AS WELL. A REPLACEMENT FOR THESE 4 ITEMS IS NEED TO THE (B)(4) OFFICE. NO SURGICAL DELAY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11171471 ↗
• MalfunctionNov 13, 2020Break; Break

  IT WAS REPORTED THAT THE RECLAIM NECK TRIAL SNAPPED WHILE TIGHTENING IT ON THE TRIAL. THE INTERNAL MECHANISM BROKE. ALL PIECES WERE RECOVERED. DID NOT AFFECT THE OUTCOME OF THE SURGERY. INSERTER HANDLE FOR CUP BROKE AT BACK SCREW JUNCTION. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10837617 ↗
• MalfunctionOct 19, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE 75MM PROXIMAL BODY SCREWDRIVER SITE IS STRIPPED. ALSO, THE RECLAIM STEM INSERTER HANDLE IS DAMAGED. NO SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10698383 ↗