SUMMIT POROCOAT 1570-11-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10603295060055), received between May 5, 2015 and Jan 8, 2026 — classified as 117 injuries.

The most frequently reported specific device problem is “Biocompatibility” (19 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 117 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM CAUSED BY PERIPROSTHETIC FRACTURE. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 24006020 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INITIAL HIP SURGERY DONE (B)(6) 2025 AT (B)(6). UNFORTUNATELY, THE PATIENTS HIP BECAME INFECTED. DR. OPTED TO DO AN IMMEDIATE EXCHANGE WHERE HE WAS GOING TO TAKE OUT ALL THE IMPLANTS, THOROUGHLY WASHOUT THE HIP, THEN IMPLANT NEW COMPONENTS. THE PATIENT WAS PREPPED WITH A 52MM EMPHASYS CUP, WHICH ALLOWED DR. TO UTILIZE A 40MM LINER FOR ADDED STABILITY. THE FEMORAL CANAL WAS THEN PREPPED FOR A 5HI STEM AND A TRIAL REDUCTION WAS PERFORMED WITH A 40MM +1.5 HEAD. DR. FELT THAT THE 40 +5 WAS BETTER AND IMPLANTED IT. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ACTIVITY LEVEL - YES. DOI: (B)(6) 2025, DOE: UNKNOWN, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23069104 ↗
• InjuryJan 31, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND THE SUMMIT WITH POROCOAT STEM AND BIOLOX DELTA CERAMIC FEMORAL HEAD WERE EXPLANTED DUE TO SUBSIDENCE AND SUBSEQUENT FRACTURE OF THE FEMUR. THE FRACTURE WAS REDUCED AND STABILIZED USING CERCLAGE WIRES AND A NEW SUMMIT WITH POROCOAT STEM AND BIOLOX DELTA CERAMIC HEAD WERE IMPLANTED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 21284952 ↗
• InjuryJan 14, 2025Adverse 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 A FALL IN PHYSICAL THERAPY. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fall

  MAUDE report 21147380 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6) 2024, MEDICAL RECORDS NOTED THE PATIENT IS 6 WEEKS POST HIP ARTHROPLASTY. IT WAS SAID THAT THE PATIENT HAD A CT SCAN TWO WEEKS AGO AND IT SHOWED A PULMONARY EMBOLISM. THE PATIENT WAS PRESCRIBED ELIQUIS MEDICATION AND OVERALL IS DOING WELL. ON (B)(6) 2024, THE PATIENT IS NOW 3 ½ MONTHS OUT FROM A RIGHT TOTAL HIP IT WAS NOTED THAT THE PATIENT HAD A PE AFTERWARDS. DEPUY STEM AND CUP ARE REPORTED TO BE WELL PLACED ON A RADIOGRAPH.

  Patient problems: Pulmonary Embolism

  MAUDE report 20280861 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO INFECTION. SURGEON REMOVED ALL PARTS INCLUDING A 56MM PINNACLE CUP, 36X56MM METAL LINER, 36MM METAL FEMORAL HEAD, SIZE 4 HIGH OFFSET SUMMIT FEMORAL STEM. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19455257 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID:(B)(6) STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT:(B)(6) 2024 DATE OF EVENT: (B)(6) 2024 (RIGHT HIP) TREATMENT: OPEN REDUCTION INTERNAL FIXATION

  Patient problems: Limb Fracture

  MAUDE report 19351109 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: MEDICAL RECORDS RECEIVED ON AD (B)(6) 2024 WERE REVIEWED BY A CLINICIAN TO IDENTIFY PATIENT HARM/PRODUCT ISSUES. CLINIC NOTE DATED (B)(6) 2024: PATIENT WITH LEFT THA BEING SEEN 3 MONTHS POST-LEFT TROCHANTERIC FRACTURE AND WALKING DIFFICULTY. WALKING DIFFICULTY RESOLVED WITH USE OF CANE. X-RAY REVEALS THE FRACTURE IS HEALING WELL AND HE PATIENT IS TREATED WITH PHYSICAL THERAPY.

  Patient problems: Ambulation or Postural Difficulties; Limb Fracture

  MAUDE report 19201348 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE METAL ON METAL HIP MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, RIGHT HIP PAIN, ELEVATED COBALT AND CHROMIUM LEVEL AND LARGE PSEUDOCYST. OPERATIVE NOTE REPORTED DEBRIDING OF SOFT TISSUES THAT SHOWED SIGNIFICANT METALLOSIS. NOTE SIGNIFICANT DEBRIS ALONG THE DEEP PORTIONS OF THE CAPSULE. LAB RESULT SHOWS COBALT AND CHROMIUM LEVEL WERE ABOVE 7 PPB. (B)(6); RIGHT HIP

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 18282737 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON DID AN IMMEDIATE EXCHANGE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18041330 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS PER SURGEON, PATIENT HAD PERI PROSTHETIC FACTURE. SURGEON REMOVED ALL COMPONENTS AND PUT DIAPHYSEAL STEM AND NEW HEMI COMPONENTS IN. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SITE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 17930206 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR COMPLAINT RECEIVED AD 11 AUG 2023. PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2008. DOR: (B)(6) 2014. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 17585781 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER(B)(4). REASON FOR ORIGINAL COMPLAINT. -LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, DIFFICULTY WALKING, SITTING, AND STANDING, AND SWELLING. DOI: (B)(6) 2009 - DOR: NONE REPORTED. (LEFT HIP).

  Patient problems: Adhesion(s); Discomfort; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Inflammation; Muscular Rigidity; Pain; Purulent Discharge; Scar Tissue; Swelling/ Edema; Unspecified Infection; Vomiting

  MAUDE report 17451093 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRIMARY HIP WAS DONE ON (B)(6) 2009. METAL LINER / HEAD WERE REVISED ON (B)(6) 2020; REASON UNKNOWN. THE STEM/ SHELL /SCREW+ REVISION LINER + HEAD WERE REMOVED ON (B)(6) 2023 FOR INFECTION. THERE WAS OSTEOLYSIS AND A POLY WEAR REPORTED. DOI: (B)(6) 2009; (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17318351 ↗
• InjuryJun 23, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO FALL AND FRACTURED PROXIMAL FEMUR. IMPLANT CAME LOOSE AND A RECLAIM STEM WAS INSERTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 17191784 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON FOLLOW-UP VISIT: (B)(6) 2021: PATIENT HAS HAD PERSISTENT WOUND DRAINAGE AND ELEVATED INFLAMMATORY MARKERS SINCE THE (B)(6) 2021 I&D AND A REPEAT ASPIRATION REVEALED A DEEP HIP INFECTION. ON FOLLOW-UP VISIT: (B)(6) 2021 PATIENT HAD FAILURE OF THE RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2021. PATIENT DID WELL INITIALLY AND WAS UP AND WALKING UPON GOING HOME, BUT THEN PATIENT DEVELOPED SWELLING OF THE RIGHT HIP FOLLOWED BY BLEEDING THROUGH THE INCISION ON (B)(6) 2021. DOI: (B)(6) 2013 ( CUP AND STEM ); DOI: (B)(6) 2021 ( HEAD AND LINER ); DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Arthritis; Erythema; Fluid Discharge; Hematoma; Inflammation; Limb Fracture; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16815043 ↗
• InjuryApr 21, 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) 2013; DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Erythema; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Necrosis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14165893 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ALLEGES INJURY TO MUSCLE AND TISSUE, SUFFERED ADDITIONAL SCAR TISSUE FORMATION, METALLOSIS, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE, AND LIMITATION OF DAILY ACTIVITIES. PLAINTIFF HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES, PERMANENT INSTABILITY AND LOSS OF BALANCE, SUFFERING, AND IMMOBILITY.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 13336830 ↗
• InjuryOct 15, 2021Migration; Migration

  RIGHT HIP STEM SUBSIDED AND HIP DISLOCATED. HIP STEM NEEDED TO BE REVISED. ORIGINAL DOS (B)(6) 2017. DOI: (B)(6) 2017. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12638502 ↗
• InjurySep 10, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  COMPASS CASE (B)(4) REPORT: IT WAS REPORTED THAT THE PATIENT FELL AND NEEDED TO BE REVISED DUE TO STEM SUBSIDING. THE SURGEON DECIDED TO REMOVE THE STEM AND GO UP TO A LARGER SIZE. HE ALSO CHANGED THE HEAD TO THE APPROPRIATE SIZE FOR STABILITY. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration

  MAUDE report 12454506 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM PAIN AND AGONY IN HIS RIGHT HIP AND LOWER EXTREMITY FOR WHICH HE CONTINUES TO SEEK MEDICAL TREATMENT. DIO: (B)(6) 2010, DOR: NONE REPORTED, (RIGHT HIP). UPDATE AD 30 AUG 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF, IMPLANT RECORDS, AND MEDICAL RECORDS. THERE WERE NO NEW ALLEGATIONS AND NO REVISION REPORTED. AFTER REVIEW OF MEDICAL RECORDS, REVISION NOTES REPORTED. ADDED PATIENT'S DOB AND LAW FIRM. UPDATED PATIENT'S INITIALS, AND PRODUCT DETAILS OF UNKNOWN LINER AND HEAD. DOI: (B)(6) 2010, DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Fatigue; Pain

  MAUDE report 12433423 ↗
• InjuryJun 16, 2021Degraded; Degraded

  ASR CLAIM RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS RIGHT HIP METALLOSIS WITH SOFT TISSUE REACTION. PATIENT EXPERIENCED PAIN AND DISCOMFORT AND ELEVATED METAL ION. OPERATIVE FINDINGS STATED THAT THERE WAS SIGNIFICANT CORROSION AT THE HEAD AND NECK JUNCTION OF FEMORAL STEM. THERE WERE SIGN OF PSEUDOTUMOR. REVISION NOTES STATED THAT SYNOVIAL FLUID WAS OBTAIN FOR CULTURE. DOI: (B)(6) 2007; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain; Unspecified Tissue Injury

  MAUDE report 12009003 ↗
• InjuryMay 21, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT PATIENT STEPPED OFF A STAIR AND FRACTURED HER PROXIMAL FEMUR STARTING JUST BELOW THE LESSER TROCHANTER. STEM SUBSIDED, WAS SHORT AND LOOSE. CUP WAS NOT REVISED. DOI: (B)(6) 2021 ,DOR: (B)(6) 2021 RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 11864528 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2021.

  Patient problems: Limb Fracture

  MAUDE report 11699558 ↗
• InjuryFeb 17, 2021Degraded; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED ELEVATED METAL ION LEAVING A ¿VERY LARGE DEAD SPACE TO MANAGE. PLAINTIFF HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE AND DEBILITATING INJURIES, ECONOMIC LOSS, AND OTHER DAMAGES INCLUDING, BUT NOT LIMITED TO, COST OF MEDICAL CARE, REHABILITATION, PERMANENT INSTABILITY AND LOSS OF BALANCE, IMMOBILITY, AND PAIN AND SUFFERING. PLAINTIFF HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, PHYSICAL DISABILITY, ECONOMIC LOSSES, AND OTHER DAMAGES, AS SET FORTH IN THIS COMPLAINT.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Extraskeletal ossification; Fever; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Necrosis; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11338673 ↗