RECLAIM 1976-18-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295077077), received between Apr 12, 2018 and Jun 10, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. ALL COMPONENTS WERE REMOVED. PATIENT HAS MULTIPLE SURGERY DATES, (B)(6) 2020. (B)(6) 2022. (B)(6) 2025. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22175822 ↗
• 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 21322981 ↗
• InjuryMar 29, 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 16635251 ↗
• 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 11005289 ↗
• 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 10992137 ↗
• 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 9342815 ↗
• 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: (B)(6) 2019, RIGHT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8688263 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 8064243 ↗
• 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 7731051 ↗
• InjuryJul 9, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE OF THE RECLAIM STEM. IT WAS ALSO REPORTED THAT THE PATIENT WANTED TO BE LONGER ON OPERATIVE SIDE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 7670204 ↗
• InjuryApr 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THE GUIDE POST WOULDN¿T PROPERLY THREAD INTO THE DISTAL RECLAIM STEM, AND THE SURGEON FELT IT DAMAGED THE THREADS INSIDE THE STEM. THE ASSEMBLY TOOL ALSO WOULDN¿T THREAD INTO THE DISTAL STEM PROPERLY, SO THE SURGEON DECIDED TO PUT IN A NEW DISTAL STEM. THE 18X140 WAS COMPROMISED AND COULDN¿T BE USED. DOE: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7424579 ↗

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