RECLAIM 1975-24-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295076919), received between Jul 11, 2017 and Nov 18, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL AND HAD A PERI PROSTHETIC FX OF HIS PRIMARY HIP IMPLANT. STEM WAS REMOVED A COMPETITOR'S RECLAIM WAS PUT IN. LABS CAME BACK THE NEXT DAY AND PT HAD A STAFF INFECTION. SO, ALL IMPLANTS WERE REMOVED AGAIN AND A STAGE 1/1 REVISION WAS PERFORMED. ACTIVITY LEVEL: YES. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23581604 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6), AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT (B)(6), 70-YEAR-OLD MALE. PATIENT EXPERIENCED A POST OPERATIVE SUPERFICIAL WOUND INFECTION REQUIRING ANTIBIOTICS AND WOUND VAC. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 23526183 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM SAINT VINCENT HOSPITAL AND HEALTH CARE CENTER, AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER: (B)(6), 70-YEAR-OLD MALE. PATIENT EXPERIENCED AN INTRAOPERATIVE BONE FRACTURE (LOCATION NOT STATED) TREATED BY CABLING. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Limb Fracture

  MAUDE report 23525821 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED. ALL COMPONENTS (EXCEPT CUP) WERE REMOVED AND NEW IMPLANTS WERE INSERTED AFTER IRRIGATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21687090 ↗
• InjuryFeb 6, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS APPROXIMATELY 6 WEEKS POST-OP AND SUSTAINED A PERI-PROSTHETIC FRACTURE DUE TO A FALL. STEM WAS FOUND TO BE LOOSE. NON-CEMENTED LOOSENING WAS REPORTED. REVISION SURGERY WAS NECESSARY TO STABILIZE PATIENT'S HIP JOINTS AND ASSOCIATED COMPONENTS. BOTH PIECES OF THE MODULAR RECLAIM STEM WERE REMOVED AND REPLACED. THE HEAD WAS REVISED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 21322983 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 18979887 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO AN INFECTION. SURGICAL DELAY IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17540870 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO AN INFECTION. SURGICAL DELAY IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17540751 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD CONVERSION FROM HEMI TO TOTAL HIP DUE TO STABILITY ISSUES. DOI: (B)(6) ,2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 15393709 ↗
• InjuryApr 27, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED AS "WE DID A REVISION LAST WEEK AND THE PATIENT RETURNED WITH PAIN A FEW DAYS LATER AND IT WAS DISCOVERED THAT THE PATIENT HAD A FRACTURE BELOW THE STEM. WE REMOVED THE RECLAIM AND APPLIED WIRES TO REDUCE FRACTURE AND PREPARED AND IMPLANTED A LONGER RECLAIM STEM." IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11732398 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP WITH POSSIBLE INSTABILITY. REMOVE RECLAIM PROXIMAL BODY AND RECLAIM STEM. DOI: (B)(6) 2018. DOR: (B)(6) 2020. UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10391810 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BEING REVISED FOR SUSPECTED LOOSE RECLAIM STEM. AFTER DISASSEMBLING THE STEM IN SURGERY, THE PROXIMAL BODY WAS REMOVED FROM THE DISTAL STEM. THE DISTAL STEM WAS FOUND TO BE WELL FIXED AND NOT LOOSE. IT WAS DISCOVERED THAT THE PATIENT HAD A PROXIMAL FEMUR FRACTURE, UNSURE IF IT WAS CAUSED IATROGENICALLY OR IF IT WAS ALREADY THERE. DECISION WAS MADE MY SURGEON TO LEAVE PREVIOUS RECLAIM DISTAL STEM AND IMPLANT A NEW PROXIMAL BODY OF A DIFFERENT SIZE EVEN AFTER THE REP ADVISED AGAIST THIS ANS STATED IT WAS OFF LABEL USE. LINER AND HEAD WERE ALSO REMOVED AND REPLACED. NO FURTHER PATIENT INFORMATION AVAILABLE DOI: 2012, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10154233 ↗
• InjuryMay 27, 2020Loss of Osseointegration; Unintended Movement; Loss of Osseointegration; Unintended Movement

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE STEM SUBSIDED,WENT UP ANGLED. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10094194 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS OUT DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020, LEFT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9757851 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED HIP AND THE SURGEON REMOVED ALL THE IMPLANTS. DOI: (B)(6) 2019; DOR: MAY 22, 2019, RIGHT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8688283 ↗
• InjuryJul 30, 2018Loose or Intermittent Connection; Migration; Loose or Intermittent Connection; Migration

  IT WAS REPORTED THAT THE RECLAIM STEM APPEARED TO BE DRASTICALLY UNDERSIZED AND IT ROTATED INTO A HIGHLY ANTEVERTED POSITION WITHIN THE PROXIMAL FEMUR. IT WAS ALSO STATED THAT THE STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7731028 ↗
• InjuryApr 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT'S INFECTED REVISION HIP WAS REMOVED AND THEN REPLACED WITH A PROSTALAC HIP UNTIL THE INFECTION IS CLEAR. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7435884 ↗
• InjuryJul 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6700217 ↗

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-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
• 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