RECLAIM 1975-24-095Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295076933), received between Jul 10, 2018 and Nov 12, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K102080); they may or may not involve this specific model.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS HIP RESECTION DONE AND WAS BROUGHT IN FOR REIMPLANTATION ON (B)(6) 2024. A RECLAIM MODULATION STEM WAS IMPLANTED AT THAT TIME WITH A DIFFERENT COMPANY ACETABULAR COMPONENT. PATIENT CAME IN FOR RESECTION DUE TO INFECTION ON (B)(6) 2025. ALL DEPUY COMPONENTS AND THE ACETABULAR COMPONENTS WERE REMOVED. A NEW PROSTALAC FEMORAL STEM WAS IMPLANTED WITH A DIFFERENT COMPANY CONSTRAINED POLY ACETABULAR COMPONENT. ALL NECESSARY INFORMATION HAS BEEN PROVIDED IN THE COMPLAINT FOR REPORTING. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23537544 ↗
• MalfunctionJun 4, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT INSIDE OF IMPLANT BOX OF THE RECLAIM PROXIMAL BODY WAS DAMAGED. THERE WERE HOLES IN THE HARD PLASTIC OUTER PACKAGING. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142825 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION OF A RECLAIM BIMENTUM WAS DONE. THE REASON FOR REVISION WAS DUE TO INSTABILITY. THE PATIENT PREVIOUSLY HAD A GIRDLESTONE PROCEDURE, AND WAS LIKE THAT FOR A NUMBER OF YEARS. THE SURGEON NOTED THAT DURING THE PRIMARY SURGERY THEY WERE STABLE ON THE TABLE WITH A 24X95 RECLAIM BODY, BUT THEIR ADDUCTOR MUSCLES WERE GONE, AND SURROUNDING TISSUES WERE DYSFUNCTIONAL. AT SOME POINT AFTER SURGERY PATIENT MOVED INTO A POSITION (WHICH THE SURGEON ADVISED NOT TO) AND THEY DISLOCATED. THE RECLAIM BODY, BIMENTUM POLY AND 28+8.5 CERAMIC HEAD WERE REMOVED. CUP WAS RETAINED. THEN A LONGER BODY, NEW POLY AND 28+12 HEAD WERE IMPLANTED. THE SURGEON SAID THAT THE PATIENT'S SOFT TISSUES ARE VERY POOR, AND THEY HAVE NO ADDUCTOR MUSCLES. NO PREVIOUS REVISION HAD BEEN DONE FOR DISLOCATIONS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 21696090 ↗
• InjuryJun 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS A 20 TO 30-MINUTE SURGICAL DELAY IN ATTEMPTING TO SEPARATE THE BODY WHICH WAS UNSUCCESSFULLY DONE. NO REPORTS OF PATIENT HARM.

  Patient problems: Unspecified Infection

  MAUDE report 19614907 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO FRACTURE. NOTHING FURTHER TO REPORT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17904085 ↗
• InjuryApr 3, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. THERE WAS A LOOSENING AT BONE TO CEMENT INTERFACE WITH UNKNOWN CEMENT MANUFACTURER. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 16662397 ↗
• InjurySep 21, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CUP REVISION AND REPLACEMENT OF RECLAIM PROXIMAL BODY DUE TO DISLOCATION. DURALOC CUP WAS REMOVED AND REPLACED WITH A COMPETITOR DUAL MOBILITY CONSTRUCT. THE RECLAIM PROXIMAL BODY WAS REMOVED AND REPLACED WITH A NEW ONE WITH DIFFERENT RETROVERSION. THERE WAS NO SURGICAL DELAY OR PATIENT HARM. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15461839 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PERI PROSTHETIC PLATING DUE TO BREAK BELOW FEMORAL STEM DUE TO FALL. NO HARDWARE WAS REMOVED. NO SURGICAL DELAY. DOI- (B)(6) 2020. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14621470 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ALL IMPLANTS REMOVED. A PROSTALAC WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2021, (UNKNOWN SIDE).

  Patient problems: Unspecified Infection

  MAUDE report 12934279 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INFECTION. ALL IMPLANTS REMOVED. A PROSTALAC WAS IMPLANTED. DOI: (B)(6) 2021 DOR: (B)(6) 2021 LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12933686 ↗
• InjuryOct 29, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO STATED THAT THE STEM SPUN AND SUBSIDED BECAUSE IT WAS LOOSE. THE PATIENT HAS HAD MULTIPLE REVISIONS SO BONE QUALITY WAS A MAJOR ISSUE. SO THE SURGEON REMOVED THE STEM AND PLACED IN THE 31MM RECLAIM. HE ALSO REPLACED WITH A NEW POLY AND HEAD AS WELL. DOI: (B)(6) 2018. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10755781 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RECLAIM BODY + HEAD REVISED FOR INFECTION. SHELL WAS A COMPETITOR PRODUCT. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10266374 ↗
• InjuryJul 10, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF FEMORAL STEM AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 7674568 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102080. One submission often covers many models, so check the product and lot details in each record.

• Z-2083-2014 · Jun 3, 2014 · Terminated
  RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking ta
• Z-2082-2014 · Jun 3, 2014 · Terminated
  RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during
• Z-2084-2014 · Jun 3, 2014 · Terminated
  RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surf