RECLAIM 10-185-4018Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295533702), received between Nov 8, 2023 and Nov 11, 2025 — classified as 3 injuries.

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 3 most recent of 3 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

  UPDATED EVENT DESCRIPTION: SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR HIP REVISION - INFECTION DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 13 OCT 2025, DATE OF IMPLANT: ON (B)(6) 2025, DATE OF REVISION: ON (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (STEM, HEAD). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 101854018, LOT NUMBER: 4442962, COMPONENT TYPE: STEM, DESCRIPTION: RECLAIM MONOBLOC REVISION STANDARD STEM 18 STANDARD OFFSET. CATALOG NUMBER: 473246028, LOT NUMBER: 4838000, COMPONENT TYPE: HEAD, DESCRIPTION: EMPHASYS 46 MM X 28 MM AOX MOBILE BEARING HEAD. CATALOG NUMBER: 472556046, LOT NUMBER: 4671538, COMPONENT TYPE: LINER, DESCRIPTION: EMPHASYS 56-58 MM X 46 MM DUAL MOBILITY LINER. CATALOG NUMBER: 471056300, LOT NUMBER: 4925729, COMPONENT TYPE: SHELL, DESCRIPTION: EMSYS SHL 3HOLE 56. CATALOG NUMBER: 121735500, LOT NUMBER: PU209417, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW 35MM. CATALOG NUMBER: 121745500, LOT NUMBER: PU216737, COMPONENT TYPE: SCREW, DESCRIPTION: CANCELLOUS BONE SCREW 45MM. CATALOG NUMBER: 136528310, LOT NUMBER: 4369950, COMPONE

  Patient problems: Unspecified Infection

  MAUDE report 23522578 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD HER HIP REVISED BY THE SURGEON WHERE HE REMOVED A HIP SCREW FROM THE PATIENT'S HIP FROM A PREVIOUS SURGERY YEARS AGO FROM A HIP FRACTURE. THE PATIENT HIP JOINT DEVELOPED ARTHRITIS SO THE DECISION WAS MADE TO REMOVE THE HIP SCREW AND DO A TOTAL HIP. THE FEMUR WAS BEING PREPPED FOR A RECLAIM MONOBLOC HIP STEM AND UNFORTUNATELY THE FEMUR FRACTURED WHEN THE SURGEON WAS REMOVING THE REAMER AFTER TRIALING. IT IS UNCLEAR WITH THE SURGEON EXACTLY WHY THE FEMUR FRACTURED APPROXIMATELY 6-7CM BELOW THE FINAL REAMER. THE FRACTURE WAS REDUCED AND A ORIF WITH A LOCKING PLATE AND A CEMENTED SUMMIT STEM WAS IMPLANTED. THE 18MM RECLAIM MONOBLOC STEM WAS OPEN AND WASTED. THERE WERE NO BROKEN INSTRUMENTS TO REPORT.

  Patient problems: Limb Fracture

  MAUDE report 21283662 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INFECTION SO REMOVED ALL IMPLANTS TO ALLOW FOR INFECTION TO CLEAR. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18093909 ↗