RECLAIM 1976-16-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295077046), received between Dec 19, 2017 and Oct 29, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Issue” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Migration; Migration

  IT WAS REPORTED THAT THE RECLAIM IMPLANTS SUBSIDED. THERE WAS NO INFECTION. NO OTHER INFORMATION KNOWN. ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY. NO CEMENT WAS INVOLVED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20557297 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16294509 ↗
• InjuryDec 7, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO THE STEM WASN¿T FIXED WELL. THERE WAS A REPORTED NON-CEMENTED LOOSENING. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15931519 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL IMPLANTS OUT DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 9746310 ↗
• MalfunctionDec 19, 2017Device Issue; Device Issue

  DER STATES DURING TOTAL HIP REVISION, THE DISTAL TAPERED STEM WAS IMPLANTED AND PROXIMAL REAMING WAS PERFORMED WITH PROTECTIVE SLEEVE ON STEM. WHEN IT CAME TIME TO REMOVE SLEEVE IT WOULD NOT REMOVE. THE SURGEON STARTED TO BREAK OFF THE SLEEVE BUT IT WOULD NOT REMOVE. THE SURGEON STARTED TO BREAK OFF THE SLEEVE, THEN REMOVED THE STEM TO REMOVE THE SLEEVE. THIS WAS A HUGE ISSUE SINCE REIMPLANTATION OF STEM WAS IMPACTED FURTHER THAN PREVIOUS POSITION. SURGICAL DELAY: 10 MINS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7128471 ↗

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