SUMMIT POROCOAT 1570-01-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10603295059387), received between Jun 29, 2017 and Dec 30, 2025 — classified as 114 injuries.

The most frequently reported specific device problem is “Biocompatibility” (14 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 114 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23921548 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ORIGINAL SURGERY DATE WAS SOMETIME IN 2014. THEY DO NOT HAVE RECORDS BUT THE SURGEON WAS ABLE TO GIVE US SIZES FROM HIS PRIMAL OP NOTE. THEY WILL NOT HAVE LOT # AS WELL. THE SURGEON SAID THE PT WAS COMPLAINING OF HIP PAIN. HIS ORIGINAL PLAN WAS TO DO A POLY SWAP AND HEAD EXCHANGE BUT ONCE IN THE SURGERY HE DEALT IT WOULD BE BETTER TO EXPLANT AND MAKE SURE IT WAS NOT INFECTED DUE TO WHAT HIS SOFT TISSUE LOOKED LIKE. HE EXPLANTED ALL COMPONENTS AND REPLACED WITH AN ANTIBIOTIC SPACER. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23497016 ↗
• InjurySep 5, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INITIAL HIP SURGERY DONE BY SURGEON AT HOSPITAL. UNFORTUNATELY, PATIENT SUFFERED A PERIPROSTHETIC FRACTURE OF THEIR FEMORAL COMPONENT. THE STEM APPEARED TO HAVE SUBSIDED, FRACTURING THE FEMUR. ANOTHER SURGEON REMOVED THE STEM AND FEMORAL HEAD AND PREPPED THE PATIENT FOR A COMPETITOR FEMORAL COMPONENT. PER SURGEON THE CUP WAS POSITIONED WELL AND WAS SECURE, SO HE OPTED TO ONLY CHANGE THE POLYETHYLENE. ONCE NEW LINER WAS IMPLANTED AND COMPETITOR FEMORAL COMPONENTS WERE IMPLANTED, A TRIAL REDUCTION WAS PERFORMED AND THE HIP WAS FOUND TO BE STABLE. FINAL CLOSING TOOK PLACE. NO OTHER ADVERSE EVENTS OR DELAYS TOOK PLACE. ACTIVITY LEVEL - YES. DOI-(B)(6) 2015. DOR- UNKNOWN. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 22977660 ↗
• InjuryFeb 6, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT UNDERWENT REVISION OF SUMMIT SIZE 7 HIP STEM. PATIENT COMPLAINED OF PAIN AND STEM SEEMED TO BE LOOSE ON X-RAY. THE STEM LOOSENING INTERFACE IS NON-CEMENTED. STEM WAS REVISED TO A LARGER SUMMIT STEM. THE SURGICAL DELAY IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21327011 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT TOTAL HIP REVISION DUE TO FAILED METAL ON METAL LEFT HIP TOTAL REPLACEMENT. OSTEOPHYTES FOUND. DOI: (B)(6) 2010. DOR: (B)(6) 2015. AFFECTED AREA: LEFT HIP.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19620272 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO A COMPETITIVE MODULAR STEM DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 18684788 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR NOTIFIED ON (B)(6) 2022 THAT PATIENT WOULD HAVE A LT HIP REVISION WITH DUAL MOBILITY. IT IS REPORTED TO BE AN ASR XL . DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Discomfort; Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 18425271 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORD RECEIVED. LITIGATION ALLEGES ASR ALLEGES SEVERE PAIN AND DISCOMFORT, INCREASED METAL LEVELS IN BLOOD INCLUDING COBALT AND CHROMIUM; PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT; ECONOMIC DAMAGES. DOI: (B)(6) 2008; DOE: (B)(6) 2022, RIGHT HIP.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Metal Related Pathology; Muscle/Tendon Damage; Pain; Unspecified Tissue Injury

  MAUDE report 17404357 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A TWO-STAGE HIP REVISION IN PERIPROSTHETIC INFECTION.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Metal Related Pathology; Muscle/Tendon Damage; Pain; Pneumonia; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17317809 ↗
• InjuryJun 2, 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. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2019, DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17048984 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED DUE TO LEFT HIP METALLOSIS STATUS POST-HIP ARTHROPLASTY.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Deformity/ Disfigurement; Depression; Discomfort; Distress; Foreign Body Reaction; Metal Related Pathology; Muscle/Tendon Damage; Pain; Unspecified Tissue Injury

  MAUDE report 16787493 ↗
• InjuryMar 21, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS INVOLVED IN AN ACCIDENT RESULTING IN A PERI PROSTHETIC FRACTURE, IN WHICH THE DOCTOR DURING SURGERY FELT THE STEM WAS LOOSE DUE TO THE FRACTURE AND REPLACED WITH A RECLAIM REVISION STEM. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 16583200 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR REMOVAL OF HEMI HIP DUE TO INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16296573 ↗
• InjuryJun 29, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED TO SURGEON CLINIC WITH LEFT HIP PAIN, HOSPITAL AND SURGERY DATE OF INITIAL IMPLANTS WAS NOT PROVIDED. X-RAYS REVEALED PATIENT HAS SUMMIT STEM/PINNACLE CUP. IN SURGERY ON 7/6/2021, IT WAS REVEALED THE PATIENT HAD A PINNACLE 56 METAL LINER/ 40 +1.5 METAL HEAD. PINNACLE CUP WAS FOUND TO BE WELL INTACT. UNABLE TO SEE THE LOT AND PART NUMBER OF ITEMS REMOVED, BEST EFFORT IS PROVIDED BELOW. THE SURGEON KEPT PINNACLE CUP, REPLACED LINER WITH POLY LINER AND CERAMIC TS HEAD. DOI: (B)(6) 2008, LEFT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 14852532 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF RIGHT TOTAL HIP, SUMMIT STEM, 40 -2 HEAD AND 40 METAL ON METAL LINER WITH 60 PINNACLE SECTOR CUP. ONLY THE SUMMIT STEM WAS RETAINED. CUP, LINER, HEAD, BONE SCREW WERE EXPLANTED. A BIOMET CUP WAS PUT IN WITH BIOMET LINER. 40 +8.5 CERAMIC TS HEAD WAS PLACED ON SUMMIT STEM. EXPLANATION FOR REVISION WAS NOT PROVIDED TO THE REPRESENTATIVE. IT WAS NOT NOTED AT THE TIME OF SURGERY THAT THERE WAS A DEFICIENT PRODUCT. IT WAS NOTED BY THE SURGEON IT IS A METAL ON METAL LINER. DOI: UNKNOWN - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cellulitis; Cyst(s); Fever; Foreign Body Reaction; Metal Related Pathology; Neuralgia; Pain; Swelling/ Edema

  MAUDE report 14734530 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN IRRIGATION AND DEBRIDEMENT FOR INFECTION. STEM AND HEAD WERE REMOVED AND REPLACED WITH NEW COMPONENTS. THE ACETABULAR COMPONENTS ARE ZIMMER BIOMET. DOI: (B)(6) 2022. DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 14315668 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND HAD A FRACTURE IN FEMUR. SUMMIT STEM, HEAD AND LINER WERE REMOVED AND USED THE DUAL MOBILITY WITH A ZIMMER ARCOS STEM. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14278226 ↗
• InjuryMar 15, 2022Osseointegration Problem; Osseointegration Problem

  MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS PAINFUL/FAILED LEFT TOTAL HIP ARTHROPLASTY. REVISION NOTES STATED THAT FLUID WAS EVACUATED. ACETABULAR COMPONENT WHICH WAS NOTED TO BE OSSEOINTEGRATED REASONABLE ABDUCTION SLIGHT RETROVERSION. THERE WAS GROSSLY LOOSE AND SUBSIDED FEMORAL STEM. THERE WAS EXTENSIVE SCAR TISSUE THROUGHOUT THE HIP. DOI: (B)(6) 2009, DOR: (B)(6) 2019 (LEFT HIP).

  Patient problems: Inadequate Osseointegration; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 13770422 ↗
• InjuryMar 15, 2022Use of Device Problem; Use of Device Problem

  PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INSTABILITY, SUBLUXATION, CLUNKING OF THE HIP. OPERATIVE NOTE REPORTED THE HIP WAS SUBLUXING ANTERIORLY. THERE WAS SOME EXCESSIVE LONGITUDINAL INSTABILITY OF THE HIP, SEROUS DRAINAGE WAS ENCOUNTERED IN THE HIP JOINT AND SOME EXCESSIVE ANTEVERSION. SHORTENING WAS PERFORMED RESULTED TO SOME ANTERIOR INSTABILITY. DOI: (B)(6) 2005; DOR: (B)(6) 2005; LEFT HIP.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 13769764 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO SUSPECTED INFECTION. SURGEON REPORTED SUMMIT FEMORAL STEM AND PINNACLE CUP WAS WELL FIXED. SURGEON ALSO REPORTED PATIENT HAD DONE WELL POST TOTAL HIP REPLACEMENT PRIOR TO A FALL WHICH HAD CAUSED A PERIPROSTHETIC FRACTURE. THE FRACTURE WAS TREATED WITH A STRYKER TROCHANTERIC HOOK PLATE AND HEALED BUT SUBSEQUENTLY BECAME INFECTED. THE HOOK PLATE WAS REMOVED AND THE INFECTION TREATED BUT NOT RESOLVED.

  Patient problems: Fall; Limb Fracture; Unspecified Infection

  MAUDE report 13712062 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STEM WAS IMPLANTED ON (B)(6) 2021 AND NEEDED REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE ON (B)(6) 2021. DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 13117859 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INFECTED, SO ALL IMPLANTS WERE REMOVED. PATIENT HAD AN INFECTION PREVIOUSLY AND SURGEON DID A SINGLE STAGE REVISION ON (B)(6). DOI: (B)(6) 2021; DOR: (B)(6) 2021; ( LEFT HIP).

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

  MAUDE report 12268004 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED SO ALL IMPLANTS WERE REMOVED. PATIENT HAD AN INFECTION PREVIOUSLY AND DR (B)(6) DID A SINGLE STAGE REVISION ON (B)(6). NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021. LEFT HIP.

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

  MAUDE report 12260307 ↗
• InjuryJul 29, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED DUE TO FEMUR FXD, SUBSIDED AFTER PT FELL IN BATHROOM AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 12245756 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. DOI: (B)(6) 2021: DOR: (B)(6) 2021: LEFT HIP.

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

  MAUDE report 12084050 ↗