RECLAIM 1977-18-190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295077213), received between Aug 25, 2017 and Sep 27, 2022 — classified as 5 injuries, 1 malfunction.

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

• MalfunctionSep 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DISTAL STEM IMPLANT WOULD NOT RELEASE FROM THE RECLAIM DISTAL STEM INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15495068 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REAMED TO A 18MM DIAMETER REAMER. INSERTED THE 18MM X 190 STEM AND THE STEM SUNK BELOW THE DESIRED 85MM MARK. SURGEON THEM EXTRACTED THE STEM AND STARTED TO REAM UP TO A 19,20,21MM. THE SURGEON NOTICED A POP WHEN REAMING THE 21MM REAMER. THE SURGEON THEN TOOK AN XRAY AND NOTICED A FEMUR FRACTURE ABOVE THE FEMUR. IMPLANTED A 21MM X 190 STEM AND THEN REPAIRED THE FRACTURE WITH A SYNTHES FEMORAL LOCKING PLATE. THE SURGEON DID MENTION THAT WE THOUGHT THE 18MM X 190 STEM POTTED ON A EXISTING FRACTURE THEN SUNK BELOW THE DESIRED LEVEL. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10402223 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATED / INFECTED LEFT HIP: DISLOCATION - RE-OCCURRENCE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION (REVISION #1): (B)(6) 2013, DATE OF IMPLANTATION (REVISION #2): (B)(6) 2013, DATE OF EVENT (ONSET): (B)(6) 2018, (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9150723 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIRST STAGE REVISION OF HIP JOINT REPLACEMENT DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8645526 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS AND ADDITIONAL INFORMATION SUBMITTED BY THE PLAINTIFFS TO DEPUY RECEIVED. LITIGATION RECORDS PERTAIN TO A PREVIOUS REVISION SURGERY. REASON FOR REVISION WAS NOT PROVIDED BUT IT WAS INDICATED THAT THE HEAD AND STEM WERE REMOVED. DOI: (B)(6) 2016 - DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Host-Tissue Reaction; No Code Available

  MAUDE report 8609456 ↗
• InjuryAug 25, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT WAS REVISED TO ADDRESS STEM SUBSIDENCE.

  Patient problems: No Information

  MAUDE report 6821591 ↗

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-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