RECLAIM 1975-20-075Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295076872), received between Jan 9, 2017 and Aug 25, 2025 — classified as 39 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HIP DONE IN 1998 WHICH WAS REVISED IN 2015. PATIENT HAS AN INFECTION AND IS NOT VERY HEALTHY. DOCTOR CHOSE TO REMOVAL ALL PARTS THAT HE COULD EASILY REMOVE AND WASH OUT AS BEST HE COULD AND ABLE TO REMOVE THE PROXIMAL BODY AND HEAD EASILY. THE DISTAL STEM (240MM) WAS WELL FIXED AND EVEN AFTER HOOKING UP THE STEM INSERTER AND SLAP HAMMER SHOWED NO SIGNS OF LOOSENING. THE CUP WAS A COMPETITOR PRODUCT. AFTER IRRIGATING AND DEBRIDEMENT PUT THE SAY SIZE IMPLANTS BACK IN AND THEN REDUCED THE HIP. ACTIVITY LEVEL - YES. DOI: 1998. DOR: 2015. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22891471 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATED HIP. COMPETITOR CUP AND HEAD WERE REMOVED AND ANOTHER COMPETITOR CUP WAS INSERTED DUE TO INSTABILITY. A NEW PROXIMAL BODY FOR RECLAIM WAS INSERTED WITH A DEPUY HEAD. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22017475 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 21610710 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO INSTABILITY. THE SURGEON REMOVED THE PROXIMAL BODY, HEAD AND LINER AND IMPLANTED NEW IMPLANTS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 21054729 ↗
• InjuryOct 29, 2024Migration; Migration

  IT WAS REPORTED THAT THE RECLAIM IMPLANTS SUBSIDED. THERE WAS NO INFECTION. NO OTHER INFORMATION KNOWN. ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY. NO CEMENT WAS INVOLVED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20557438 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURE THE EVENT. ON (B)(6) 2013, THERE IS A NEW TRANSVERSE PERIPROSTHETIC FRACTURE OF THE LEFT GREATER TROCHANTER PERIPROSTHETIC FRACTURE OF THE LEFT GREATER TROCHANTER WITH MILD SUPERIOR DISPLACEMENT OF THE FRACTURE FRAGMENT. INTACT BILATERAL TOTAL HIP ARTHROPLASTIES WITH LEFT PROXIMAL FEMORAL CERCLAGE WIRES. DOI: (B)(6) 2012. DOE: (B)(6) 2013. LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 19407680 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. PLEASE CLARIFY WHICH STEM WAS REVISED. AS IN DER THERE ARE 2 RECLAIM STEM: RECLAIM PRX BDY CONE 20X75 RECLAIM DISTAL TAPERED 16X140 - THE TWO PARTS ARE DIFFERENT AND, WHEN ASSEMBLED, MAKEUP THE STEM. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? - NO DELAY C. WAS THERE ANY ALLEGATION AGAINST THE LINER? - NO ALLEGATION AGAINST THE LINER.

  Patient problems: Limb Fracture

  MAUDE report 18947269 ↗
• InjuryDec 21, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF RECLAIM DISTAL TAPERED STEM AND PROXIMAL BODY AT BONE TO IMPLANT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 202.3. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18380351 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE REMOVAL WAS DUE TO THE NAIL CUT-OUT FROM THE FEMORAL NECK WITH SECONDARY REPOSITION LOSS.

  Patient problems: Unspecified Infection

  MAUDE report 18372077 ↗
• MalfunctionSep 5, 2023Incomplete or Missing Packaging; Missing Information; Incomplete or Missing Packaging; Missing Information

  MISSING PRODUCT THAT HAD NOT BEEN PREVIOUSLY REPORTED AS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684389 ↗
• InjuryAug 9, 2023Migration; Migration

  THE PATIENT WAS REVISED AS THE SURGEON REPORTED THE STEM SUBSIDED AND WAS DISLOCATED. THE SURGEON WAS AWARE OF THE LABEL TO KEEP THE EXISTING STEM AND PUT A NEW PROX BODY BUT THE STEM WAS SOLID. THE PROX BODY, HEAD, LINER WERE REMOVED AND THE EXISTING CUP AND DISTAL STEM WERE KEPT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 17487927 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN, DOR- (B)(6) 2023, AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16294516 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FEMUR FRACTURE, SO ON THE REVISION CASE WE CABLED THE FEMUR AND REPLACED THE STEM WITH A LONG CONSTRUCT. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 16052545 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIRST STAGE REVISION FOR INFECTION OF TOTAL HIP JOINT PROSTHESES. PRIMARY OPERATION DONE ON (B)(6) 2022. DOI: (B)(6) 2022; DOR: (B)(6) 2022; UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13890343 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 13591268 ↗
• InjuryNov 24, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12870021 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, WASHOUT PERFORMED AND SAME SIZES COMPONENTS REIMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12489515 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. COMPONENTS WERE REPLACED FOR THE SAME SIZES AFTER THE WASHOUT WAS PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12489456 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS INFECTED SO HE REMOVED RECLAIM PROXIMAL BODY AND HEAD TO A GIRDLESTONE. THE CUP COMPONENTS WERE REMOVED AS WELL BUT THEY WERE A COMPETITIVE COMPANY¿S IMPLANTS. DR. BROWN CHOICE TO LEAVE THE DISTAL RECLAIM STEM BECAUSE IT WAS WELL FIXED AND DIDN¿T WANT TO RISK FRACTURING PATIENTS FEMUR. STEM THAT WAS LEFT IN WAS REF# 1977-27-240 LOT#110412. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12439313 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED TOTAL HIP JOINT REPLACEMENT. HAD PERIPROSTHETIC HIP FRACTURE WHICH WAS REVISED WITH A RECLAIM FEMORAL COMPONENT ON (B)(6) 2021. DEVELOPED INFECTION AND HASN'T BEEN DISCHARGED FROM THE HOSPITAL SINCE THAT ADMISSION. NOT SURE OF WHAT ANTIBIOTIC REGIME SHE IS CURRENTLY ON. DAIR PROCEDURE PERFORMED AND THE BODY WAS REPLACED, STEM REMAINED INSITU DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT (B)(6) , WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: INFECTION, DID PATIENT REQUIRE REVISION SURGERY? FALSE, IF YES, DATE OF REVISION SURGERY. (B)(6) 2021, REASON FOR REVISION SURGERY. INFECTION, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? X-RAY, ANTIBIOTICS, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12267178 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 11387758 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE REMOVED AND REPLACEMENT OF A SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11004588 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO UNSTABLE ACETABULAR CUP AND DRAINING SINUS FROM LEFT HIP RESULTING TO PAINFUL AND INFECTED LEFT HIP ARTHROPLASTY. OPERATIVE NOTE REPORTED THERE WAS EXTENSIVE EVIDENCE OF A SINUS TRACT, INFECTION PRESENT AND LAB RESULT CONFIRMED INCREASE WBC. CUP WAS GROSSLY LOOSE AND SCAR TISSUE WERE REMOVED. DOI: (B)(6) 2015: DOR: (B)(6) 2019; LEFT HIP (2ND REVISION).

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10992120 ↗
• MalfunctionSep 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECLAIM ASSEMBLY TOOL FOR PLACING 2000 PSI GOT STUCK IN IMPLANT AFTER THE TENSILE BAR APPROPRIATELY BROKE. HAD TO TAKE OUT ENTIRE CONSTRUCT. SURGICAL DELAY OF ONE HOUR REPORTED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10538496 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9342930 ↗

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