SUMMIT POROCOAT 1570-01-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295059394), received between Mar 24, 2016 and Jul 25, 2025 — classified as 38 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON FRACTURED THE CALCAR WHILE IMPLANTING THE FEMORAL COMPONENT. THE STEM WAS REMOVED AND REPLACED WITH A COLLARED STEM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 22610195 ↗
• InjuryJun 3, 2025Migration; Migration

  IT WAS REPORTED THAT THE STEM WAS SINKING DEEPER IN THE CANAL SO THE PATIENT WENT FROM A SIX STANDARD TO AN EIGHT STANDARD. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED AREA: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 22134878 ↗
• InjuryNov 22, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS THE STEM BECAME LOOSE AND HAD TO BE REMOVED FOR A LONGER STEM. NO CEMENT HAD BEEN USED. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20761640 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A FRACTURE OF THE FEMUR. THE SURGEON REVISED THE STEM TO A RECLAIM MODULAR. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2011. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 20506049 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. PATIENT EXPERIENCED ANXIETY DUE TO ALL THE DAMAGE THAT THE ASR HAS CAUSED AND ABOUT ANY FUTURE DAMAGE THAT THE HIGH LEVELS AND METAL IN HIS BLOODSTREAM CAN CAUSE.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Inflammation; Metal Related Pathology; Muscle/Tendon Damage; Nerve Damage; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 17482512 ↗
• InjuryAug 16, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON TOOK ALL IMPLANTS OUT DUE TO INFECTION. THERE WAS A REPORTED NON-CEMENTED LOOSENING OF FEMUR AND CUP. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 15232904 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO SEPTIC RIGHT TOTAL HIP HAD FAILED CONSERVATIVE TREATMENT INCLUDING LAVAGE WITH COMPONENT RETENTION, LOOSENING OF THE ACETABULAR COMPONENT. THE PLATE ITSELF HAD FRACTURED AND IT WAS GROSSLY LOOSE WITH PURULENT FIBROUS TISSUE, SOME DRAINAGE PRESENT AND HAD BEEN OVERGROWN BY HETEROTOPIC BONE. THE ACETABULUM ITSELF WAS ERODED WITH SEVERAL SMALL AREAS OF FULL-THICKNESS PENETRATION, NECROTIC DEBRIS WAS NOTED IN THE FLOOR OF THE ACETABULUM. DOI: (B)(4) 2010, DOR: (B)(4) 2010 , RIGHT HIP.

  Patient problems: Adhesion(s); Extraskeletal ossification; Necrosis; Pocket Erosion; Unspecified Infection

  MAUDE report 13769911 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SUMMIT STEM WAS REMOVED DUE TO THIGH PAIN APPROXIMATELY 2 YEARS AFTER INDEX. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT HIP.

  Patient problems: Pain

  MAUDE report 12303457 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEING REVISED FOR PERIPROSTHETIC FEMORAL FRACTURE AROUND A WELL FIXED SUMMIT PRESS-FIT STEM. STEM WAS LEFT IN PLACE, FEMUR WAS CABLED TOGETHER WITH 3 DEPUY SYNTHES 1.7MM CABLES. NEW 28MM HEAD AND 59 BIPOLAR HEAD WERE IMPLANTED. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 10718066 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME TO ER DISLOCATED. SURGEON EXPLANTED CURRENT 53 UNIPOLAR HEAD BALL AND +5 TAPERED SLEEVE AND BEGAN TRIALING WITH + 5 28 MM AND 53 BIPOLAR HEAD BALL WITHOUT LUCK OF STABILITY. HE THEN TRIALED WITH +8.5 28MM HEAD BALL AND STILL WAS DISSATISFIED WITH STABILITY. HE DECIDED TO EXPLANT SUMMIT STEM (8STD) AND IMPLANT 8 HI SUMMIT STEM WITH + 5 28MM HEAD BALL WITH A DUAL MOBILITY COMPETITOR MDM CUP. SURGEON STATED HE WAS DISPLEASED WITH DEPUY¿S ABILITY TO PROVIDE A DUAL MOBILITY PINNACLE IMPLANT. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10362430 ↗
• InjuryMar 24, 2020Naturally Worn; Naturally Worn

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN. LAB RESULTS TAKEN ON (B)(6) 2019 INDICATE THAT BLOOD CHROMIUM AND COBALT LEVELS WERE BELOW 7. LABORATORY STUDIES WERE SUGGESTIVE OF TRUNNIONS. OPERATIVE FINDINGS INCLUDE A FASCIAL RENT, METALLOSIS-APPEARING FLUID, TRUNNIONS AND NOTCHING IN THE FEMORAL NECK AREA DUE TO IMPINGEMENT BETWEEN THE FEMORAL NECK AND ACETABULAR SOCKET. THE CUP HAS SIGNIFICANT ANTEVERSION. DOI: (B)(6) 2009, DOR: (B)(6) 2019, (RIGHT HIP).

  Patient problems: Edema; Foreign Body Reaction; Joint Disorder; No Code Available; Pain; Tissue Damage

  MAUDE report 9872107 ↗
• InjuryNov 26, 2019Corroded; Degraded; Naturally Worn; Corroded; Degraded; Naturally Worn

  REVISION DUE TO PAIN, PSEUDOTUMOR, HEMATOMA, EROSIONS, NECROTIC TISSUE, METAL DEBRIS, ELEVATED METAL IONS, AND STEM CORROSION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Foreign Body Reaction; Hematoma; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Pain; Pocket Erosion; Test Result; Tissue Damage

  MAUDE report 9375520 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS RIGHT HIP WAS REVISED WITH AN I&D HEAD/LINER EXCHANGE DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8992533 ↗
• InjuryJul 10, 2019Loss of Osseointegration; Loss of Osseointegration

  ALTHOUGH THERE ARE NO PATIENT SPECIFIC ALLEGATIONS, GENERAL LITIGATION ALLEGES METAL ON METAL, THEREFORE WE ARE REPORTING THE LINER AND THE HEAD. PPF ALLEGES LOOSENING OF THE STEM AND BONE FRACTURE. DOI: (B)(6) 2006. DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8776922 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION CONFIRMED THAT THE IMPLANT SIDE WAS THE LEFT HIP. DOI IS (B)(6) 2019.

  Patient problems: Infarction, Cerebral

  MAUDE report 8650671 ↗
• InjuryMay 10, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT SUFFERS FROM PAIN. PF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009, DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Pain

  MAUDE report 8598917 ↗
• InjuryApr 26, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES SUFFERS FROM A FAILED PINNACLE HIP. UPDATE AD 10 AUG 2018: RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result

  MAUDE report 8554869 ↗
• InjuryApr 23, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES PATIENT SUFFERS FROM IMPLANT FAILURE, METALLOSIS, SEVERE PAIN, SWELLING, INFECTION, BURSITIS AND LACK OF MOBILITY. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2013 (RIGHT HIP).

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

  MAUDE report 8541278 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED DUE TO PAIN. UPDATE LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AND EXHIBITED SYMPTOMS OF A LOOSE IMPLANT. UPDATE THE REVISION OPERATIVE NOTE INDICATED BLACK STAINING. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: (B)(6) 2015 (LEFT HIP).

  Patient problems: Discomfort; No Code Available; Pain; Test Result

  MAUDE report 8522524 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGED INJURY, PAIN, SUFFERING AND EMOTIONAL DISTRESS. UPDATE 1: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGE COULD NOT WALK PROPERLY , PAIN, AND FATIGUE, LACK OF SLEEP AND RASHES. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAIN. REVISION NOTES REPORTED BROWNISH DISCOLORATION OF THE SOFT TISSUE IN AND AROUND THE SYNOVIUM AT THE HIP SOCKET JOINT. UPDATE 2: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES CUP LOOSENING, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2009; DOR: (B)(6) 2016; RIGHT HIP.

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

  MAUDE report 8486821 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR PAINFUL LEFT THA, LIKELY SECONDARY TO METAL DEBRIS FROM METAL-ONE METAL REPLACEMENT. THERE WAS SOME LARGE AMOUNT OF BONE ANTERIORLY, WHICH MAY REPRESENT SMALL OSTEOPYES OR SOME HETEROTROPIC CALCIFICATION. THE DEEP TISSUES OF THE HIP WERE NOT STAINED WITH METAL DEBRIS.

  Patient problems: Discomfort; Extraskeletal ossification; Joint Disorder; No Code Available; Pain; Test Result

  MAUDE report 8469127 ↗
• InjuryMar 21, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, IT WAS CONFIRMED THAT THE PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Test Result; Unspecified Infection

  MAUDE report 8439263 ↗
• InjuryMar 18, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES PAIN AND DISCOMFORT. UPDATE AD 10 JUL 2018: PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

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

  MAUDE report 8427839 ↗
• InjuryMar 15, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, METALLOSIS, AND DIFFICULTY WALKING. UPDATE AD 13 JUL 2018: PPF ALLEGES ELEVATED METAL IONS AND METAL ON METAL WEAR. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS METAL ON METAL HYPERSENSITIVITY. REVISION NOTE STATED, THERE WERE PURULENCE AND PATHOLOGY SHOWED NO ACUTE INFLAMMATION.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8424277 ↗
• InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE PPF, STICKER SHEETS AND IMPLANT RECORDS RECEIVED. PPF ALLEGES OPEN AND CLOSED DISLOCATION, CONSTRAINED LINER AND ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2010; DOR: (B)(6) 2011; (LEFT HIP).

  Patient problems: Test Result

  MAUDE report 8407568 ↗