SUMMIT 1570-12-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295060154), received between Aug 10, 2017 and Sep 11, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Biocompatibility” (15 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient fell and broke lateral side of the bone. Surgeon removed the Summit stem and implanted a revision stem. Surgeon swapped out the liner and head also.DOI: (b)(6) 2013.DOR: (b)(6) 2026.Affected Side: Left Hip.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 50733399 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INFECTION ON OCT 30, 2020. THE PATIENT WAS TREATED WITH IRRIGATION AND DEBRIDEMENT. (B)(4) CAPTURES INFECTION AND IS TREATED WITH I & D. AND IS LINKED TO (B)(4) WHICH CAPTURES LOOSENING, METALLOSIS, SYNOVITIS, PAIN, DISCOMFORT, AND EMOTIONAL DISTRESS. LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18220282 ↗
• InjuryFeb 10, 2022Osseointegration Problem; Osseointegration Problem

  ASR LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES LOOSENING, METALLOSIS, SYNOVITIS, PAIN, DISCOMFORT AND EMOTIONAL DISTRESS. DOI: (B)(6), 2007. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Discomfort; Distress; Foreign Body Reaction; Inadequate Osseointegration; Pain; Synovitis

  MAUDE report 13505796 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A 58 MM ASR CUP, 1-1 SPACER, AND 51 ASR HEAD. PATIENT HAS A PAIN AND ELEVATED METAL ION LEVELS. SURGEON REMOVED CUP, HEAD AND SPACER. SHE LEFT THE STEM IN PATIENT IMPLANTED IN 64MM MULTI HOLE GRIPTION CUP, +4/10 40MM LINER AND A +8.5MM TS CERAMIC 40MM HEAD. DOI: (B)(6) 2008 - DOR: (B)(6) 2021 (LEFT HIP).

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

  MAUDE report 12846392 ↗
• InjuryOct 22, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION SURGERY AND WAS REPLACED WITH NON DEPUY PRODUCTS. CUP, SLEEVE, AND HEAD WERE REMOVED. PATIENT UNDERWENT SECOND REVISION DUE TO DISLOCATION. HOWEVER, NON DEPUY PRODUCTS WERE INVOLVED. DOI: (B)(6) 2008, DOR: (B)(6) 2020, (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discomfort; Distress; Dyspnea; Foreign Body Reaction; Hearing Impairment; Hypersensitivity/Allergic reaction; Pain; Renal Failure

  MAUDE report 12680455 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. WASH OUT PERFORMED. STAGED FOR FUTURE PROSTALAC. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT HIP.

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

  MAUDE report 12129196 ↗
• InjuryApr 28, 2021Degraded; Degraded

  MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS METALLOSIS WITH PAIN. REVISION NOTES STATED THAT THE FEMORAL HEAD WAS REMOVED FROM THE TRUNNION. THERE WAS NOTED TO BE SOME TRUNNIONOSIS WITH BLACKENED STAINING AT THE TRUNNION. THE LINER WAS REMOVED. THE REMAINING METALOSIS WAS REMOVED. SURGICAL PATHOLOGY REPORT STATED THAT FRAGMENTS OF SKELETAL MUSCLE, FIBROADIPOSE TISSUE, AND MILDLY REACTIVE SYNOVIUM WITH MILD CHRONIC PREDOMINANTLY HISTIOCYTIC INFLAMMATION, MILD HEMOSIDEROSIS AND METALLOSIS AND RARE FOREIGN BODY GIANT CELL REACTION AROUND REFRACTILE WEEKLY BIREFRINGENT PARTICLES. LEFT HIP BONE AND TISSUE CONSIST OF MULTIPLE PINK TAN SOFT TISSUE FRAGMENTS MEASURING 7.2X6.4X1.1CM IN AGGREGATE. NO ACUTE INFLAMMATION DIAGNOSTIC OF INFECTION SEEN. DOI: (B)(6) 2009 - DOR: (B)(6) 2019 (LEFT HIP).

  Patient problems: Foreign Body Reaction; Inflammation; Pain; Unspecified Tissue Injury

  MAUDE report 11736654 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING IMPLANTS WERE REMOVED TODAY BY SURGEON AT (B)(6) HOSPITAL PROXIMAL FEMORAL FRACTURE WAS THE REASON FOR REVISION. ORIGINAL SURGERY DATE APPROX ONE WEEK AGO.

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

  MAUDE report 10736438 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUMMIT SIZE 4 STEM INSERTED AND REMOVED FROM PATIENT DUE TO BONE FRACTURING AND STEM SUBSIDING. SURGEON REQUEST TO REMOVE SUMMIT STEM AND INSERT A C-STEM.

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

  MAUDE report 10254427 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THA ON (B)(6) 2020. ON (B)(6) 2020 SURGEON MADE US AWARE THAT THE PATIENT HAD EXPERIENCED A PERIPROSTHETIC FRACTURE DISTALLY ON HER RIGHT HIP. ON (B)(6) 2020 WE EXPLANTED A SUMMIT DOUFIX SZ 4 HIGH OFFSET STEM AND A DELTA CERAMIC HEAD 12/14 32MM +9. THERE WAS NO DAMAGE TO THE IMPLANTS. THE TWO IMPLANTS WERE REMOVED AND DISPOSED OF. I AM UNSURE OF HOW SHE FRACTURED HER FEMUR. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.

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

  MAUDE report 9745867 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS FAILED THA RESULTING TO PAIN. OPERATIVE NOTE REPORTED LEG LENGTH DISCREPANCY DUE TO REDUCE STEM. DOI: (B)(6) 2009; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 9591091 ↗
• InjuryOct 30, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES INFECTION AND LOOSENING OF THE STEM AFTER THE FIRST REVISION. THERE WERE NO OPERATIVE NOTES PROVIDED. DOI: (B)(6) 2003, (CUP / STEM / TWO SCREWS). DOI: (B)(6) 2015, (UNK LINER AND UNK HEAD). DOR: NONE REPORTED, (RIGHT HIP). PLEASE SEE (B)(4) FOR THE RIGHT HIP FIRST REVISION.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 9254860 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PPF ALLEGES INFECTION AND LOOSENING OF THE CUP HOWEVER, AFTER RE-REVIEW OF MEDICAL RECORDS, THERE WAS NO CONFIRMATION OF THE ALLEGED INFECTION AND LOOSENING.

  Patient problems: Foreign Body Reaction; Limited Mobility Of The Implanted Joint; Pain; Unspecified Infection

  MAUDE report 9238385 ↗
• InjuryOct 17, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORD RECEIVED. PPF ALLEGES DISLOCATION, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS BEFORE FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THERE IS NO REVISION NOTES PROVIDED. DOI: (B)(6) 2002; DOR: (B)(6) 2003; RIGHT HIP.

  Patient problems: Foreign Body Reaction; No Code Available; Test Result

  MAUDE report 9203220 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GREATER TROCHANTERIC BROKE DURING REHAB. HIP DISLOCATED POSTERIOR SHORTLY AFTER. DOI: (B)(6) 2019; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 9141377 ↗
• InjuryJun 6, 2019Degraded; Degraded

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS METALLOSIS AND METAL ION RELEASE. AN MRI WAS DONE WHICH SHOWED MODERATE METALLOSIS AND SYNOVIAL HYPERTROPHY. OPERATIVE FINDINGS INCLUDE A MODERATE AMOUNT JOINT FLUID AND CORROSION ON THE TRUNNION. DOI: (B)(6) 2006 - DOR: (B)(6) 2018 (RIGHT HIP). PATIENT IS A BILATERAL. OTHER HIP IS ON (B)(4).

  Patient problems: Foreign Body Reaction; No Code Available; Test Result; Tissue Damage

  MAUDE report 8674540 ↗
• InjuryMay 13, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE 24 JUL 2018: (B)(4) WAS REOPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, OPERATIVE NOTES REPORTED NO ABNORMALITIES.

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8603199 ↗
• InjuryMay 13, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE: 6/3/13 - LITIGATION PAPERS RECEIVED. DATE OF IMPLANT HAS BEEN PROVIDED. THERE IS NO ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THIS INVESTIGATION. UPDATE REC'D 1/28/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE RIGHT HIP REVISION OPERATIVE NOTE IT CONFIRMED METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 02/19/14. UPDATE 24 JUL 2018: (B)(4) WAS REOPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, NO REVISION NOTES WERE PROVIDED. ADDED LAWYER AND LAW FIRM, PATIENT MIDDLE INITIAL, NEW IP (STEM) AND UPDATED PRODUCT DETAILS. DOI: (B)(6) 2011 - DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8603180 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2005 (STEM). DOI: (B)(6) 2016 (HEAD). DOR: NOT REPORTED (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8575035 ↗
• InjuryMay 1, 2019Biocompatibility; Biocompatibility

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8568585 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, DISCOMFORT AND DIFFICULTY AMBULATING. UPDATE THE REVISION SURGERY NOTED THAT ONE OF THE SCREW HEADS STRIPPED, AND THE ACETABULAR COMPONENT HAD A SMALL AMOUNT OF BONY INGROWTH AND THE MAJORITY OF THE INGROWTH WAS FIBROUS. DOI: (B)(6) 2009; DOR: (B)(6) 2014; LEFT HIP.

  Patient problems: No Code Available; Test Result

  MAUDE report 8535224 ↗
• InjuryApr 18, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND WEAKNESS. UPDATE 01/12/17 ¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE PFS AND MEDICAL RECORDS FOR MDR REPORTABILITY, ALLEGES PAIN, DIFFICULTY WALKING, GETTING IN AND OUT OF CAR, INABILITY TO DO LIQUID HOUSEKEEPING CHORES, DEPRESSION, LIMITED RANGE OF MOTION AND WEAKNESS IN HIP AND LEG, AND TROUBLE SLEEPING. REVISING SURGEON NOTED IN DESCRIPTION THAT "ANTERIOR HALF OF ABDUCTORS WERE AVULSED, AND THERE WAS APPROXIMATELY 100 ML OF YELLOW-TINGED FLUID IN THE HIP". ALSO, "SOME METAL STAINING AROUND THE PERIPHERY OF THE ACETABULUM". THE "METAL STAINED LINING" WAS SENT FOR PATHOLOGY, "WHICH WAS NEGATIVE FOR ACUTE INFLAMMATION, BUT POSITIVE FOR PERIVASCULAR LYMPHOCYTIC INFILTRATION CONSISTENT WITH AN ADVERSE REACTION TO THE METAL-ON-METAL BEARING". ALTR AND POOR JOINT MECHANICS: ROM HARMS ADDED TO COMPLAINT, AND FDA CODES FOR ALTR, LOSS OF ROM, DEPRESSION, AND WEAKNESS SUBMITTED. UPDATE AD 30 AUG 2018: RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. ADDED STEM DUE TO ELEVATED METAL IONS.

  Patient problems: Depression; Inflammation; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Test Result; Tissue Damage; Weakness

  MAUDE report 8528078 ↗
• InjuryApr 17, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PFS AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS NOW LEGAL. PATIENT HAD A PRIMARY HIP DONE ON 6/15/2009 FOR HIS RIGHT HIP. HE IS REPORTING PAIN, DECREASED MOBILITY, AND METALLOSIS. UPDATE AD 30 AUG 2018: RECEIPT OF PPF AND IMPLANT RECORDS. PPF ALLEGES PSEUDOTUMOR, CONSTRAINED LINER, LOOSENING OF CUP, INFECTION, METAL WEAR AND ELEVATED METAL IONS.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8522426 ↗
• InjuryApr 15, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2006; DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: Pain; Test Result; Tissue Damage

  MAUDE report 8513799 ↗
• InjuryApr 10, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8500723 ↗