RECLAIM 1976-16-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295077039), received between Dec 13, 2017 and Nov 11, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HEALTH CARE CENTER, AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER (B)(6), 70-YEAR OLD MALE. PATIENT EXPERIENCED A POST OPERATIVE SUPERFICIAL WOUND INFECTION REQUIRING ANTIBIOTICS AND WOUND VAC. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 23526212 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE (B)(6), WHICH INCLUDES INFORMATION COLLECTED FROM (B)(6) HOSPITAL AND (B)(6), AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER (B)(4), 70-YEAR-OLD MALE. PATIENT EXPERIENCED AN INTRAOPERATIVE BONE FRACTURE (LOCATION NOT STATED) TREATED BY CABLING. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2024.

  Patient problems: Limb Fracture

  MAUDE report 23525832 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 18979880 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RECLAIM STEM REVISED FOR PERIPROSTHETIC FRACTURE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2019. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 18947266 ↗
• MalfunctionAug 9, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PROTECTION COVER WAS DIFFICULT TO REMOVE. SEVERAL INSTRUMENTS WERE USED TO REMOVE IT. THERE WAS A 5 MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12293188 ↗
• MalfunctionJun 24, 2021Incomplete or Missing Packaging; Missing Information; Incomplete or Missing Packaging; Missing Information

  IT WAS REPORTED THAT THE RECLAIM DISTAL STEM HAS NO TAPER PROTECTOR COVER, AND THE CAUTION NOTICE WAS NOT FOUND IN THE PACKAGE OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058269 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP WITH POSSIBLE INSTABILITY. REMOVE RECLAIM PROXIMAL BODY AND RECLAIM STEM. DOI: (B)(6) 2018, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 10391794 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9342935 ↗
• InjuryDec 13, 2018Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  STEM FRACTURE.

  Patient problems: No Code Available

  MAUDE report 8159743 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES WALKING DIFFICULTY AND PAIN.

  Patient problems: Ambulation or Postural Difficulties; Pain; Test Result

  MAUDE report 7938180 ↗
• InjuryDec 13, 2017Malposition of Device; Malposition of Device

  DER STATED THAT THE PATIENT HAD DISLOCATED HIP AND WAS BROUGHT TO OR FOR OPEN REDUCTION. IT WAS ALSO STATED THAT THE STEM SEEMED TO NOT HAVE ENOUGH ANTEVERSION WHEN RELOCATED AND CHECKED FOR STABILITY. DOI: (B)(6) 2017; DOR: (B)(6) 2017 RIGHT HIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7112139 ↗

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