RECLAIM 1977-16-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295077176), received between Nov 19, 2019 and Nov 29, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE REMOVAL WAS DUE TO THE NAIL CUT-OUT FROM THE FEMORAL NECK WITH SECONDARY REPOSITION LOSS.

  Patient problems: Unspecified Infection

  MAUDE report 18231136 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON 05/15/2012 PATHOLOGY REPORT SHOWS SEVERAL OF THE FRAGMENTS ARE NECROTIC IN APPEARANCE, ONE OF THE FRAGMENTS SHOWS CHRONIC INFLAMMATORY CELLS. ON (B)(6) 2012, THE PATIENT HAD AN EXTENDED FEMORAL OSTEOTOMY, REMOVAL OF TOTAL HIP COMPONENTS INCLUDING BOTH FEMORAL AND ACETABULAR COMPONENTS, IMPLANTATION OF CEMENT SPACER WITH ANTIBIOTICS TO ADDRESS PROBABLE INFECTION IN THE LEFT HIP. PATIENT WAS REPORTED TO HAVE HAD PAIN. PRIOR TO THIS REVISION, THE PATIENT HAD SEVERAL INJECTIONS TO ATTEMPT TO ALLEVIATE THE PAIN WITH LIMITED SUCCESS. DURING THIS REVISION SURGERY, THE SURGEON OBSERVED SILVER DISCOLORATION TO THE JOINT FLUID. ALL COMPONENTS WERE REVISED DUE TO THE PROBABLE INFECTION. AN EXTENDED OSTEOTOMY WAS REQUIRED TO REMOVE THE WELL-FIXED FEMORAL STEM. (NO MENTION OF THE MANUFACTURER OF THE COMPONENTS REMOVED OR THE COMPONENTS IMPLANTED IN THE CURRENT MEDICAL RECORDS). CEMENT SPACERS WERE PLACED DURING THIS PROCEDURE. (B)(4). *ON (B)(6) 2012, THE PATIENT HAD A REVISION OF LEFT TOTAL HIP ARTHROPLASTY, REIMPLANTATION AND FINISHING OF THE SECOND STAGE, TO ADDRESS POST INFECTED LEFT TOTAL HIP ARTHROPLASTY. IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS TROCHANTER

  Patient problems: Metal Related Pathology; No Code Available; Test Result; Unspecified Infection

  MAUDE report 9341398 ↗

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