RECLAIM 1975-24-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295076940), received between Sep 26, 2017 and Jun 20, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR LEFT HIP SWELLING. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2013. DATE OF EVENT: 30 MAY 2024. (LEFT HIP) TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 19575752 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. REMOVAL OF ALL IMPLANTS TOOK PLACE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16777450 ↗
• InjuryDec 3, 2020Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT STEM SUBSIDED SO THE SURGEON REVISED AND WENT UP IN DIAMETER AND LENGTH IN STEM. IT WAS ALSO REPORTED THAT THE STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10938464 ↗
• 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 9596712 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL HIP REPLACEMENT PERFORMED POST PERI PROSTHETIC FRACTURE. RECLAIM STEM REMOVED AND LONG RECLAIM STEM INSERTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7942387 ↗
• InjurySep 26, 2017Migration or Expulsion of Device; Loss of Osseointegration; Migration or Expulsion of Device; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS UNDERSIZED STEM, SUBSIDENCE AND STEM LOOSENING AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: No Information

  MAUDE report 6894626 ↗

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-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-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