SUMMIT POROCOAT 1570-11-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10603295060048), received between Aug 10, 2017 and Apr 23, 2025 — classified as 77 injuries.

The most frequently reported specific device problem is “Biocompatibility” (10 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 77 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STEM AND BIPOLAR WERE REVISED FOR PERIPROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 21889893 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER THE SURGERY, A PERIPROSTHETIC FEMORAL FRACTURE OCCURRED. THE PRODUCT IN QUESTION WILL BE OR WAS REMOVED ON AN UNKNOWN DATE TO BE REPLACED WITH A COMPETITOR PRODUCT. THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Limb Fracture

  MAUDE report 21719201 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PRIMARY SURGERY WAS PERFORMED VIA THA WITH THE IMPLANT IN QUESTION. ON AN UNKNOWN DATE, THE PERI-STEM FRACTURE WAS CONFIRMED. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2023. DOI: (B)(6) 2014. DOE: PENDING. AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 17744850 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN, STEM WAS REMOVED THOUGHT IT WAS LOOSE BUT IT WAS NOT REMOVED ANYWAY , CUP HAD A METAL ON METAL LINE COULD NOT GET LINER TO DISENGAGE SO TOOK THE CUP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP

  Patient problems: Pain

  MAUDE report 16707428 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO TRANSVERSE ACETABULAR FRACTURE AND INFECTION. DOI: NOVEMBER 18,2020, DOR: FEBRUARY 2,2023, AND AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16403256 ↗
• InjuryFeb 14, 2023Adverse 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 PLACED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SITE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16371890 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP INFECTION. HEAD, LINER, AND STEM WERE REMOVED. WOUND WAS THOROUGHLY IRRIGATED, AND NEW COMPONENTS WERE INSERTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16213776 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP. REMOVED ALL IMPLANTS. THERE WAS NO REPORTED LOOSENING. IT WAS UNKNOWN IF ANY SURGICAL DELAY OCCURRED. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15391412 ↗
• InjuryAug 18, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSE SUMMIT POROUS PRESS FIT FEMORAL STEM. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15249563 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORD RECEIVED. LITIGATION ALLEGES SEVERE PAIN, DISCOMFORT, ELEVATED METAL IONS, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, PERMANENT INJURIES AND ECONOMIC DAMAGES. DOI: (B)(6) 2008; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 15191806 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, PFS AND MEDICAL RECORDS RECEIVED. PPF ALLEGES COMPONENT FRACTURE, DISLOCATION WITH CLOSED REDUCTION, AND ELEVATED METAL IONS. PFS ALLEGES HIP DISLOCATION, BONE AND MUSCLE DAMAGE, PAIN AND LIMITED RANGE OF MOTION. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC HIP RECURRENT INSTABILITY, DISLOCATION, DISRUPTION OF CONSTRAINED LINER WITH SUBLUXED, EXTENSIVE OSTEOLYSIS IN THE FEMUR AND ACETABULUM AND SLIGHTLY ELEVATED METAL IONS. OPERATIVE NOTE REPORTED SOME MODERATE TENDINOPATHY DUE TO METAL WEAR DEBRIS FROM OLD SURGERY, SCAR TISSUES AROUND THE ACETABULUM AND FEMUR. SOME METAL PIECES NOT RECOVERED DUE TO RISK DAMAGE THE SCIATIC NERVE AND VITAL STRUCTURES. ACETABULAR DEVICE HAD SIGNIFICANT AMOUNT OF ANTEVERSION; SUMMIT STEM WAS IMPINGING THE POSTERIOR RIM OF THE CUP. THERE WAS A MODERATE SIZE NOTCH ON THE STEM. DOI: (B)(6), 2018. DOR: (B)(6), 2021. RIGHT HIP 2ND REVISION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Limb Fracture; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Physical Asymmetry; Scar Tissue; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 14349513 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM TOXIC HEAVY METALS RESULTING TO MUSCLE, TISSUE INJURY, PAIN, METAL WEAR, SCAR TISSUE FORMATION, LIMITED ADL, EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2007. DOR: UNREVISED . LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 14186562 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2021; DOR: (B)(6) 2022 LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 13343486 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMORAL COMPONENT REVISION WAS DUE TO PERIPROSTHETIC FRACTURE SUSTAINED DURING A FALL. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 12359952 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO FRACTURE POST OP. NO SURGICAL DELAY. DOI: (B)(6) 2021: DOR: (B)(6) 2021: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 12238365 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION AND MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES THAT PATIENT STILL CONTINUES TO HAVE PAIN, SEVERE TINNITUS AND DISCOMFORT AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THERE IS NO 2ND REVISION REPORTED. DOI: (B)(6) 2008 (CUP, STEM), DOI: (B)(6) 2021 (LINER, HEAD), DOR: NONE REPORTED, RIGHT HIP.

  Patient problems: Discomfort; Pain; Tinnitus

  MAUDE report 12143985 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION AND MEDICAL RECORDS RECEIVED. LITIGATION ALLEGES PAIN LUMP ON BUTTOCKS, FREQUENT LOSS OF BALANCE CAUSING SEVERAL FALLS, SEVERE TINNITUS, METALLOSIS AND PSUEDOTUMOR. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO METAL ON METAL REACTION. OPERATIVE NOTES REPORTED THAT THERE WAS A SMALL AMOUNT OF PSEUDOTUMOR SEEN POSTERIORLY. THERE WAS ABUNDANT FLUID IN THE JOINT. THE TRUNNION HAD SOME SLIGHT BLACK RESIDUE. DOI: (B)(6) , 2008 DOR: (B)(6) , 2021 RIGHT HIP.

  Patient problems: Fall; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema; Tinnitus

  MAUDE report 12143905 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PERIPROSTHETIC FRACTURE AROUND HER SUMMIT PRESSFIT STEM. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT HIP.

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

  MAUDE report 10726528 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE, OSTEOLYSIS AND SIGNIFICANT ADVERSE LOCAL TISSUE REACTION RELATED TO MOM AND METALLOSIS RESULTING TO PAIN IN HER RIGHT HIP. OPERATIVE NOTE REPORTED GRAY FLUID AND WAS SENT FOR CULTURE. THERE WAS SOFT TISSUE REACTION WITH SIGNIFICANT METALLOSIS AND PROXIMAL OSTEOLYSIS IN THE FEMUR. THERE WAS ALSO SIGNIFICANT ASYMETRIC ANTERIOR WEAR OF THE LINER WITH DEFORMATION OF THE METAL LINER. MRI SHOWED SIGNIFICANT ADVERSE LOCAL TISSUE REACTION AND METAL IONS REPORTED ABOVE 7 PPB. DOI: (B)(6) 2008. DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bone Fracture(s); Edema; Foreign Body Reaction; Loss of Range of Motion; No Code Available; Osteolysis; Pain; Test Result; Unspecified Tissue Injury

  MAUDE report 10471043 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED ON (B)(6) 2020 BY SURGEON. I WAS NOTIFIED THE AM OF THE SURGERY THAT THE PATIENT HAD AN OFFICE VISIT WITH DR. K. UPON HER EXAMINATION, IT WAS DETERMINED THAT HER HIP WAS INFECTED AND AN I&D AS WAS TO BE DONE. DURING THE PROCEDURE SURGEON EXPLANTED ALL OF THE COMPONENTS SHE HAD IMPLANTED, DID A THOROUGH DEBRIDEMENT AND IMPLANTED A NEW SUMMIT PINNACLE CONSTRUCT. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10278109 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POST OPERATIVE FEMUR FRACTURE WAS REVISED. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT HIP.

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

  MAUDE report 10087960 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED LEFT FAILED TOTAL HIP ARTHROPLASTY PAIN, METALLOSIS, SMALL ABDUCTOR TEAR AND INFLAMMATION. OPERATIVES NOTES INDICATED ELEVATED METAL ION LEVEL AND HETEROTOPIC OSSIFICATION. DOI: (B)(6) 2007. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Calcium Deposits/Calcification; Extraskeletal ossification; Foreign Body Reaction; Inflammation; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 10076525 ↗
• InjuryMay 19, 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 LEFT HIP FAILED ARTHROPLASTY, METALLOSIS, SMALL AREA OF INFLAMMATION AND SMALL TEAR ABOUT THE ABDUCTORS. THE PATIENT COMPLAINT OF INCREASING PAIN AND THE MRI SHOWED AN AREA OF SOFT TISSUE DISRUPTION. OPERATIVE NOTE INDICATED, THERE APPEARED SOME MINOR DISRUPTION ALONG THE POSTERION CAPSULE. IT WAS ALSO INDICATED IN THE MEDICAL RECORDS THAT THE PATIENT HAS ELEVATED METAL ION LEVELS. DOI: (B)(6) 2007. DOR: (B)(6) 2019. (LEFT HIP).

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

  MAUDE report 10071323 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT ALLEGES PAIN. LABORATORY RESULT FOR METAL IONS WERE ABOVE 7PPB. DOI: (B)(6) 2008, DOR: NONE REPORTED, RIGHT HIP.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 9909870 ↗
• InjuryMar 20, 2020Corroded; Degraded; Corroded; Degraded

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED METAL ON METAL RIGHT HIP ARTHROPLASTY WITH METALLOSIS AND ABDUCTOR MUSCLE NECROSIS. OPERATIVE NOTES INDICATED ELEVATED METAL ION LEVEL, CORROSION, DISCOMFORT AND PSEUDOTUMOR FORMATION. UPON ENTERING INTO THE JOINT, THE METALLIC FLUID WAS UNDER TENSION AND HAD EVIDENCE OF METAL DEBRIS. THERE WAS EVIDENCE OF CORROSION AT THE TAPER OF THE LINER ACETABULAR COMPONENT INTERFACE WITH PSEUDOMEMBRANE FORMATION ON THE UNDERSURFACE OF THE ACETABULAR LINER. DOI: (B)(6) 2009; DOR: (B)(6) 2019 RIGHT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Necrosis; No Code Available; Pain; Test Result

  MAUDE report 9860906 ↗