RECLAIM 1976-19-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295077091), received between Dec 14, 2017 and Jul 10, 2025 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT REVISION OF HIP STEM WAS PERFORMED AFTER PERIPROSTHETIC FRACTURE. FEMORAL STEM WAS LOOSE AT NON-CEMENTED INTERFACE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 22472365 ↗
• 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 16052476 ↗
• InjuryNov 24, 2020Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF RECLAIM FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. NO SURGICAL DELAY. DOI: (B)(6) 2019 - DOR: (B)(6) 2020 (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 10896485 ↗
• InjuryJul 18, 2019Loss of Osseointegration; Unintended Movement; Loss of Osseointegration; Unintended Movement

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. STEM SUBSIDED CAUSING LEG LENGTH TO BE SHORT. DOI: (B)(6) 2018; DOR: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8804149 ↗
• MalfunctionDec 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PLASTIC PIECE WOULDN'T COME OFF DISTAL STEM, HAD TO CUT IT OFF, STEM WAS STILL IMPLANTED. THERE WAS SURGICAL DELAY OF 7 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7116635 ↗

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