RECLAIM 1976-14-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295076995), received between Nov 17, 2017 and Dec 31, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION HIP SURGERY AND RENEWAL OF ALL HARDWARE DUE TO INFECTION. SURGEON REPLACED ALL REMOVED HARDWARE WITH A PROSTALAC 240 STEM AND 56*40 POLY LINER AND 40. 1.5 CERAMIC HEAD. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21047836 ↗
• InjuryDec 21, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF RECLAIM DISTAL TAPERED STEM AND PROXIMAL BODY AT BONE TO IMPLANT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18377732 ↗
• InjuryAug 29, 2022Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem

  REVISION OF DEPUY SYNTHES RECLAIM STEM FOR LOOSENING. ORIGINAL SURGEON UNKNOWN. DATE OF SURGERY (B)(6) 2021, BELIEVED TO POSSIBLY BE (B)(6) HOSPITAL AND DR (B)(6) HOWEVER UNCONFIRMED. FEMORAL COMPONENT WAS LOOSE. NO FURTHER INFORMATION AVAILABLE AND PATIENT AND BOTH SURGEONS HAVE NOT CONSENTED TO THE SHARING OF INFORMATION INCLUDING THAT CONTAINED ON THIS DOCUMENT. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-01507643. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01507644. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-01507645. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 15311265 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE IS NO REPORTED LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 14678741 ↗
• InjuryJul 25, 2019Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  REVISION OF RECLAIM STEM FOR SUBSIDENCE/LOOSENING.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8826368 ↗
• MalfunctionJul 9, 2019Device-Device Incompatibility; Difficult to Open or Remove Packaging Material; Device-Device Incompatibility; Difficult to Open or Remove Packaging Material

  PRODUCT DETAILS: RECLAIM STEM 14MM X 140MM STRAIGHT STEM. 1976-14-140 LOT H64477 DATE: 17/6/2019. ISSUE: FEMORAL CANAL PREPARED AS PER SURGICAL TECHNIQUE. ABOVE FEMORAL STEM IMPLANTED AS PER SURGICAL TECHNIQUE. WHEN SURGEON WENT TO REMOVE TAPER PROTECTOR SLEEVE IT WOULD NOT DISENGAGE. PROXIMAL ASPECT OF SLEEVE EVENTUALLY BROKE LEAVING DISTAL PART IN SITU. STEM THEN HAD TO BE REMOVED AND ANOTHER IMPLANT OPENED AND IMPLANTED IN ITS PLACE. CASE LENGTH WAS EXTENDED BY APPROX 15 MINUTES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8771704 ↗
• InjuryMar 13, 2019Loss of Osseointegration; Loss of Osseointegration

  SUBJECT: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018, (LEFT HIP). HEAD AND LINER REVISED.

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

  MAUDE report 8415873 ↗
• InjuryOct 5, 2018Failure to Osseointegrate; Migration; Failure to Osseointegrate; Migration

  IT WAS REPORTED THAT SURGEON HAD REVISED THE PATIENT'S HIP IN JANUARY FOR A PROXIMAL FEMUR FRACTURE. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 7939385 ↗
• InjuryDec 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAD REVISION HIP USING DEPUY RECLAIM REVISION INSPECTION OF STEM. IT WAS REVEALED THAT PROXIMAL END OF STEM WAS MACHINED INCORRECTLY AND IN A WAY THAT IT PREVENTED THE PROXIMAL BODY FROM FITTING. THIS WAS CONFIRMED AFTER COMPARING IMPLANT IN QUESTION TO ANOTHER IMPLANT. DOE: (B)(6) 2017; RIGHT HIP; SURGICAL DELAY OF 1 1/2 HOURS.

  Patient problems: Not Applicable

  MAUDE report 7118443 ↗
• InjuryNov 17, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION AND STEM LOOSENING. LOOSENING OCCURRED FROM BONE TO IMPLANT. HEAD AND STEM REVISED. NO FURTHER PATIENT INFORMATION AVAILABLE.

  Patient problems: Inadequate Osseointegration; Joint Dislocation

  MAUDE report 7040921 ↗

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