RECLAIM 1976-20-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295077114), received between Dec 3, 2020 and Oct 24, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 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. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23378107 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS REVISED ALL THE IMPLANTS TO A CEMENT SPACER DUE TO AN ACTIVE INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21910137 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20081250 ↗
• 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 19575757 ↗
• InjuryNov 24, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2016 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12869924 ↗
• InjuryApr 27, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED AS "WE DID A REVISION LAST WEEK AND THE PATIENT RETURNED WITH PAIN A FEW DAYS LATER AND IT WAS DISCOVERED THAT THE PATIENT HAD A FRACTURE BELOW THE STEM. WE REMOVED THE RECLAIM AND APPLIED WIRES TO REDUCE FRACTURE AND PREPARED AND IMPLANTED A LONGER RECLAIM STEM." IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture; Pain

  MAUDE report 11732397 ↗
• 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 10938372 ↗

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-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-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