RECLAIM 1977-24-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295077381), received between Jan 16, 2020 and Feb 23, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO STEM SUBSIDENCE. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24422655 ↗
• InjuryFeb 10, 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 INFECTION AND THE SURGEON DID A SINGLE STAGE REVISION. SURGEON REMOVED ALL IMPLANTS, DID A THOROUGH I&D, AND PUT IN NEW IMPLANTS. THERE WAS NO DELAY IN PROCEDURE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21342933 ↗
• InjuryJan 16, 2020Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LOOSENING OF THE DISTAL FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. ALL FEMORAL COMPONENTS WERE REMOVED AND REPLACED WITH A LARGER RECLAIM STEM. DOI: (B)(6) 2019; DOR: (B)(6) 2020 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9596675 ↗

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-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
• 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