RECLAIM 1975-24-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295076926), received between Aug 25, 2017 and Dec 17, 2025 — classified as 28 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE IMPLANTS WERE REMOVED AND PROSTALAC WAS INSERTED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23826478 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, THE HEAD, LINER AND PROXIMAL BODY WERE REMOVED AND REPLACED AFTER WASHOUT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22979712 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS REVISED ALL THE IMPLANTS TO A CEMENT SPACER DUE TO AN ACTIVE INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21910055 ↗
• 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 21047837 ↗
• InjuryNov 15, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED, FOR PAINFUL BIPOLAR COMPONENT. THE STEM WAS FOUND TO BE LOOSE AND WAS REVISED TOO. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20693461 ↗
• InjuryNov 12, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS THERE ANY ALLEGATION AGAINST THE HEAD AND LINER? NO.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20662152 ↗
• InjuryApr 8, 2024Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY? NO SURGICAL DELAY. B. CAN YOU PROVIDE THE LOOSENING INTERFACE? THE SURGEON SAID THE PROXIMAL BODY HAD RETROVERTED.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 19067027 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION IN HIP JOINT REPLACEMENT, PREVIOUS WASHOUTS ATTEMPTED WITH INFECTION NOT RESOLVED. DECISION WAS MADE TO REMOVE ALL IMPLANTS AND REPLACE WITH CEMENT LOADED WITH ANTIBIOTICS TO DEAL WITH THE INFECTION. PLASTIC SURGEON INVOLVED TO MANAGE TISSUE LOSS. PLAN IS TO BRING HIM BACK TO THEATRE ONCE THE INFECTION IS RESOLVED AND THE WOUND HAS HEALED. IMPLANTS IN PLACE ARE RECLAIM WITH PINNACLE MULTIHOLE CUP AND BIMENTUM SHELL CEMENTED IN PLACE.

  Patient problems: Unspecified Infection

  MAUDE report 18267535 ↗
• InjuryNov 8, 2023Migration; Migration

  IT WAS REPORTED THAT THE RECLAIM STEM GOT SUBSIDED. PULLED OUT THE STEM PROXIMAL BODY, DUAL MOBILITY LINER AND HEAD. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18095189 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANTED PATIENT IMPLANTS DUE TO INFECTED HIP. DOI: UNKNOWN. DOR: (B)(6), 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16630739 ↗
• 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, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF : NONE, DEVICE IN POSSESSION OF : NONE, (B)(4). 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 15311399 ↗
• InjuryJul 11, 2022Use of Device Problem; Use of Device Problem

  REVISION OF A RECLAIM STEM FOR INSTABILITY, PROXIMAL BODY AND HEAD ONLY.

  Patient problems: Joint Laxity

  MAUDE report 14982091 ↗
• 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 14852841 ↗
• InjuryApr 29, 2022Off-Label Use; Off-Label Use

  REVISION OF A RECLAIM STEM AS THE IMPLANT FRACTURED. THE PATIENT HAD A MISS-STEP WHILE WALKING WHICH CAUSED HER TO STUMBLE. THE IMPLANT THEN FRACTURED. SEE ATTACHED PHOTO. AS A RESULT OF THE STEM FRACTURING, THIS CAUSED THE PROXIMAL FEMUR TO FRACTURE. THIS DISTAL PART OF THE STEM WAS EXTREMELY WELL FIXED AND WAS VERY DIFFICULT TO REMOVE. THE PROXIMAL PART OF THE STEM AND BODY WAS EASY TO REMOVE AS THIS PART OF THE FEMUR WAS FRACTURED CAUSING IT TO BECOME LOOSE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14251795 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY : DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR MASS IN RT POSTERIOR THIGH, HAMSTRING REGION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT (CUP): (B)(6) 2003. DATE OF IMPLANT: (B)(6) 2012. DATE OF EVENT: (B)(6) 2021. (RIGHT HIP). TREATMENT: DIAGNOSTIC MRI.

  Patient problems: Cyst(s); Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 12512579 ↗
• MalfunctionAug 17, 2021Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT INTRAOPERATIVELY BOTH THE SURGEON AND THE ATTENDING SALES REP WERE NOT ABLE TO FIX THE RECLAIM PROXIMAL NECK SEGMENT TO THE DISTAL STEM. SURGERY DELAY ABOUT 10 MINUTES, NO ADVERSE PATIENT CONSEQUENCES. LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12330350 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN IRRIGATION AND DEBRIDEMENT WITH PROXIMAL BODY SWAP. SAME CONSTRUCT WAS REIMPLANTED. DOI: (B)(6) 2021. DOR: (B)(6) 2021; (LEFT HIP).

  Patient problems: Insufficient Information

  MAUDE report 12210549 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN APPARENT INFECTION OF THE RIGHT HIP. THE SURGEON REMOVED ALL IMPLANTS AND PERFORMED AND WASHOUT & I.D. AND IMPLANTED AN ANTIBIOTIC CEMENT SPACER. DOI: (B)(6) 2019 (STEM, CONE, HEAD), DOI: (B)(6) 2017 (CUP, LINER, 2 SCREWS), DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11087181 ↗
• InjuryNov 24, 2020Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF RECLAIM FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2020 (LEFT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 10896628 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FEMUR FRACTURE, INTRAOPERATIVE: PERIPROSTHETIC FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (RIGHT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION WITH SYNTHES CERCLAGE CABLES X 3.

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

  MAUDE report 10792091 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS REVISION DUE TO THE PRESENCE OF INFECTION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10504443 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED RECLAIM BODY AND HEAD REVISED FOR CHRONIC DISLOCATION. DOI:(B)(6) 2020, DOR:(B)(6) 2020, AFFECTED SITE: UNKNOWN.

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

  MAUDE report 10096755 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THE INITIAL REVISION WAS OF JUST THE STEM SIDE ON (B)(6) 2019 AND ANOTHER REVISION TO TAKE OUT A ZIMMER CUP AND PUT IN OURS WAS DONE ON (B)(6) TO STOP THOUSAND PATIENT'S RIGHT HIP WAS REVISED DUE TO SECTION. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8583263 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 8415875 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION. DOI: (B)(6) 2014 - DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Pulmonary Embolism

  MAUDE report 8378799 ↗

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