RECLAIM 1976-21-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295077138), received between Oct 5, 2018 and Nov 8, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2023Migration; Migration

  IT WAS REPORTED THAT THE RECLAIM STEM GOT SUBSIDED. PULLED OUT THE STEM PROXIMAL BODY, DUAL MOBILITY LINER AND HEAD. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18095181 ↗
• 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 14621333 ↗
• InjuryMar 25, 2021Migration; Migration

  IT WAS REPORTED THAT THE STEM SUBSIDED AND REQUIRED REVISION. DOI: (B)(6) 2019. DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 11568261 ↗
• 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 10094193 ↗
• MalfunctionSep 30, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES LOOSENING OF THE STEM AFTER FIRST REVISION. DOI: (B)(6) 2014. DOR: NOT REPORTED, (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 9134918 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THE INITIAL REVISION WAS OF JUST THE STEM SIDE ON (B)(6) 2019 AND ANOTHER REVISION TO TAKE OUT A ZIMMER CUP AND PUT IN OURS WAS DONE ON (B)(6) TO STOP THOUSAND PATIENT'S RIGHT HIP WAS REVISED DUE TO SECTION. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8583295 ↗
• InjuryJan 17, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND STICKER SHEETS RECORD RECEIVED. PINNACLE PPF ALLEGES LOOSENING OF THE STEM AFTER FIRST REVISION.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8258316 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL HIP; (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT (B)(6) 2018. REVISION TOTAL HIP REPLACEMENT PERFORMED POST PERI PROSTHETIC FRACTURE. RECLAIM STEM REMOVED AND LONG RECLAIM STEM INSERTED.

  Patient problems: Not Applicable

  MAUDE report 7938389 ↗

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