RECLAIM 1976-15-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295077015), received between Mar 26, 2020 and Jun 29, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE HIP. SURGEON EXPLANTED ALL COMPONENTS REVISING WITH NEW STEM AND CUP W/CONSTRAINED LINER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 14852791 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE WAS THE RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 11387678 ↗
• InjuryJan 29, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON REMOVED A NON-DEPUY MEDIAL STEM DUE TO METALLOSIS: SURGEON REMOVED THE STEM AND CUP AND TO REPLACE WITH RECLAIM, AFTER PREPARATION FOR RECLAIM WITH DISTAL REAMERS, DISTAL STEM WAS INSERTED DOWN AND SURGEON TRIED TO ENGAGE THE RECLAIM BODY ONTO THE DISTAL STEM BUT IT WOULDN¿T ENGAGE. AFTER SEVERAL ATTEMPTS TAMPING THE BODY ONTO THE DISTAL STEM ANOTHER X-RAY WAS OBTAINED AND REVEALED THAT AS SURGEON WAS TRYING TO ENGAGE THE BODY TO THE STEM THE DISTAL PART OF THE STEM SPLIT THE FEMUR AND SURGEON HAD TO REMOVE THE STEM AND PROXIMAL BODY AND PUT IN A LARGER AND LONGER DISTAL DIAMETER STEM AND PREPARE THE PROXIMAL PORTION OF THE FEMUR FOR ANOTHER BODY. ONCE HE CABLED THE FEMUR SURGEON RE-TRIALED PUT IN FINAL DEPUY IMPLANTS: SURGERY TIME WAS EXTENDED TO 60 MINUTES. RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 11254628 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE EXPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10803537 ↗
• InjuryOct 15, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HIP REVISION SURGERY (RIGHT SIDE) WITH THE RECLAIM SYSTEM. WHEN PLACING THE DEFINITIVE STEM, THE PROTECTIVE CAP IS NOT REMOVED, THIS STEP OF THE SURGICAL TECHNIQUE WAS OMITTED, WHICH REMAINS IMPACTED WITHIN THE INTRAMEDULLARY CANAL. AN ATTEMPT IS MADE TO REMOVE BUT NOT ALL THE FRAGMENTS OF THE CAP CAN BE EXTRACTED, A LATERAL OSTEOTOMY IS PERFORMED TO EXTRACT THE FRAGMENTS. THE DEFINITIVE IMPLANTS ARE PLACED. THE SURGICAL TIME WAS EXTENDED AND FRAGMENTS REMAINED INSIDE THE BONE.

  Patient problems: No Code Available

  MAUDE report 10683347 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A 2 YEAR INFECTED HIP, NOT DEPUY, THAT WAS REMOVED & ANTIBIOTIC SPACER INSERTED ON (B)(6) 2019. PATIENT WAS CLEARED OF INFECTION AND ON (B)(6) 2019 A DEPUY REVISION TOTAL HIP WAS IMPLANTED. IN (B)(6) 2020, THE PATIENT PRESENTED ANOTHER HIP INFECTION AND ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9883852 ↗

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-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-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