RECLAIM 1975-20-085Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295076889), received between Aug 28, 2017 and Dec 22, 2025 — classified as 25 injuries.

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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT RECLAIM PRX BDY CONE 20X85, RECLAIM DISTAL TAPERED 14X190A, BI MENTUM ALTRX LNR 49 28, AND DELTA CER HEAD 12/14 28MM +5 WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED REVISION OF A RECLAIM STEM DUE TO LOOSENING, WITH THE STEM DESCRIBED AS UNDERSIZED AND HAVING SUBSIDED, RESULTING IN THE DISTAL TIP PROTRUDING THROUGH THE LATERAL CORTEX. THE EVENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE DEVICE WAS REPLACED OR REVISED. OTHER THAN THE NEED FOR REVISION, THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23862627 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS A LEFT TOTAL HIP THAT IS INFECTED. ALL COMPONENTS WERE REMOVED. PATIENT HAS MULTIPLE SURGERY DATES, (B)(6) 2020. (B)(6) 2022. (B)(6) 2025. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22176660 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 20080939 ↗
• InjuryMar 21, 2024Use of Device Problem; Use of Device Problem

  THE PATIENT DISLOCATED ANTERIOR/SUPERIOR ON HER ACETABULUM. REVISION OF THE PROXIMAL BODY FROM 20X85 TO LONGER BODY WITH HIGH OFFSET 24X95. THE VERSION WAS ALSO CHANGED TO ADDRESS THE GLOBAL OFFSET AND VERSION.

  Patient problems: Joint Dislocation

  MAUDE report 18951121 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED FOR INSTABILITY. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18093994 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAIN IS CREATED TO CAPTURE THE INTRA-OP EVENT. ON (B)(6) 2018 THE PATIENT HAD A REVISION OF RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS FAILED RIGHT TOTAL HIP, THE SURGEON REPORTED THAT THERE WAS A GREATER TROCHANTER FRACTURE THAT OCCURRED DURING THE PREPARATION OF NEW STEM AND A CABLE AND SYNTHES TROCHANTERIC FRACTURE PLATE AND 2 CABLES WERE USED TO STABILIZE THE FRACTURE.

  Patient problems: Limb Fracture

  MAUDE report 16783423 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16225372 ↗
• InjuryNov 29, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO THE STEM WASN¿T FIXED WELL. THERE WAS A REPORTED NON-CEMENTED LOOSENING. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15880363 ↗
• 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 14678488 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. ALL COMPONENTS WERE WELL FIXED. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14561262 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED STAGE ONE OF A TWO STAGE REVISION TO TREAT INFECTION. DOI: (B)(6) 2016; DOR: (B)(6) 2022 LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13659998 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A RECLAIM PINNACLE DM TOTAL HIP DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A LONG C-STEM WITH MARATHON CEMENTED CUP WERE IMPLANTED AS A SPACER UNTIL THE INFECTION CLEARS. I AM UNSURE OF THE DATE OF THE DATE OF SURGERY, BUT I CAN TRY FIND OUT. THESE IMPLANTS HAD NOT BEEN IN FOR LONG. MALE, RIGHT SIDE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12813216 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS ALSO OPERATED ON ON (B)(6) 2017. AN DER WAS REPORTED AT THAT TIME PATIENT HAS HISTORY OF RECURRENT INFECTION AND SEVERE PSORIATIC ARTHRITIS. PATIENT PRESENTS WITH PAIN AND XRAYS REVEALING VISIBLE GAS IN XRAYS, LEADING SURGEON TO BELIEVE PATIENT IS INFECTED. ALL COMPONENTS EXCEPT THE CUP WERE REMOVED. SURGEON FELT THAT IF THE CUP WERE REMOVED, THERE WAS NOT ENOUGH BONE TO PLACE ANOTHER SHELL INTO. A THOROUGH DEBRIDEMENT AND SUBSEQUENT IRRIGATION WAS PERFORMED. A NEW SET UP WAS UTILIZED TO REIMPLANT THE PATIENT ALONG WITH PLACEMENT OF ANTIBIOTIC BEADS. SURGEON ALSO COATED EXPOSED IMPLANTS WITH HIGH DOSE ANTIBIOTIC CEMENT. DOI: (B)(6) 2017 DOR: (B)(6) 2021 LEFT HIP.

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

  MAUDE report 11938984 ↗
• 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: Insufficient Information

  MAUDE report 11254632 ↗
• 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 10803534 ↗
• 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 9883855 ↗
• 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 9342827 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FIRST STAGE REVISION OF HIP JOINT REPLACEMENT DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8645528 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS POLY SWAP I&D FOR INFECTION WITH PROX BODY AND HEAD EXCHANGE. RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8560942 ↗
• InjuryFeb 5, 2019Loss of Osseointegration; Loss of Osseointegration

  PINNACLE PPF ALLEGES LOOSENING OF THE STEM AFTER FIRST REVISION.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8304255 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 8064253 ↗
• InjuryJul 9, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE OF THE RECLAIM STEM. IT WAS ALSO REPORTED THAT THE PATIENT WANTED TO BE LONGER ON OPERATIVE SIDE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 7670265 ↗
• InjuryDec 6, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND FEMORAL STEM LOOSENING AT THE BONE/IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7088129 ↗
• 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 7040906 ↗
• InjuryAug 28, 2017Malposition of Device; Malposition of Device

  THE PATIENT WAS REVISED TO ADDRESS RIGHT HIP DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 6823786 ↗

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-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