RECLAIM 1977-14-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295077152), received between Dec 6, 2017 and Dec 22, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT RECLAIM PRX BDY CONE 20X85, RECLAIM DISTAL TAPERED 14X190A, BI MENTUM ALTRX LNR 49 28, AND DELTA CER HEAD 12/14 28MM +5 WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED REVISION OF A RECLAIM STEM DUE TO LOOSENING, WITH THE STEM DESCRIBED AS UNDERSIZED AND HAVING SUBSIDED, RESULTING IN THE DISTAL TIP PROTRUDING THROUGH THE LATERAL CORTEX. THE EVENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE DEVICE WAS REPLACED OR REVISED. OTHER THAN THE NEED FOR REVISION, THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 23862642 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. THE PATIENT WENT THROUGH SEVERAL I&DS AND WOULD NOT GET BETTER. THE SURGEON DECIDED TO DO A HIP DISARTICULATION. THE STEM, LINER AND CUP HAD TO COME OUT. THERE WERE NO INSTRUMENTS BROKEN OR DAMAGED. ALL COMPONENTS WERE REMOVED. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection

  MAUDE report 12517272 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS ALSO OPERATED ON ON (B)(6) 2017. AN DER WAS REPORTED AT THAT TIME PATIENT HAS HISTORY OF RECURRENT INFECTION AND SEVERE PSORIATIC ARTHRITIS. PATIENT PRESENTS WITH PAIN AND XRAYS REVEALING VISIBLE GAS IN XRAYS, LEADING SURGEON TO BELIEVE PATIENT IS INFECTED. ALL COMPONENTS EXCEPT THE CUP WERE REMOVED. SURGEON FELT THAT IF THE CUP WERE REMOVED, THERE WAS NOT ENOUGH BONE TO PLACE ANOTHER SHELL INTO. A THOROUGH DEBRIDEMENT AND SUBSEQUENT IRRIGATION WAS PERFORMED. A NEW SET UP WAS UTILIZED TO REIMPLANT THE PATIENT ALONG WITH PLACEMENT OF ANTIBIOTIC BEADS. SURGEON ALSO COATED EXPOSED IMPLANTS WITH HIGH DOSE ANTIBIOTIC CEMENT. DOI: (B)(6) 2017 DOR: (B)(6) 2021 LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 11938977 ↗
• InjuryDec 6, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND FEMORAL STEM LOOSENING AT THE BONE/IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7088100 ↗

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