SUMMIT POROCOAT 1570-01-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10603295059356), received between Jan 20, 2015 and Apr 3, 2026 — classified as 128 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 129 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE PERIPROSTHETIC FRACTURE. REVISED STEM AND HEAD. AFFECTED SIDE: RIGHT.

  Patient problems: Limb Fracture

  MAUDE report 24779354 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP REMOVAL OF IMPLANTS DUE TO INFECTION. DOI: UNKNOWN , DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21855569 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUG 02, 2023 GYNECOLOGICAL MEDICAL RECORDS REPORTED RIGHT HIP SURGERY INDUCED BLOOD CLOT IN 2019. THERE WAS NO SPECIFICS PROVIDED. THERE WAS NO MENTION OF ANY INTERVENTIONS.

  Patient problems: Hematoma

  MAUDE report 18525250 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIARTICULAR FRACTURE AROUND PROSTHESIS DEVELOPED DUE TO FALL. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE : RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 18140225 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNDERGOING EXPLANT OF PRIMARY HIP COMPONENTS WITH IMPLANTATION OF A CEMENT SPACER DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17681871 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLAINTIFF FACT SHEET RECEIVED. LITIGATION RECORD ALLEGES THAT PATIENT EXPERIENCED HIP PAIN WHEN STANDING OR SITTING AND CHROMIUM AND COBALT WERE TESTES HIGH.

  Patient problems: Metal Related Pathology; Pain; Synovitis

  MAUDE report 17009851 ↗
• InjuryMay 18, 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, DISCOMFORT, INCREASED METAL LEVELS IN BLOOD INCLUDING COBALT AND CHROMIUM, PERMANENT INJURIES, EMOTIONAL DISTRESS, DISFIGUREMENT AND ECONOMIC DAMAGES. DOI:(B)(6) 2008. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Muscle/Tendon Damage; Muscular Rigidity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16952075 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FRACTURE LEFT FEMUR. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 16920715 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2022, THE PATIENT HAD A RIGHT HIP REVISION, CULTURE, IRRIGATION, AND DEBRIDEMENT TO ADDRESS HEMATOMA, CELLULITIS, AND FASCIA/GLUTEUS DEHISCENCE. THE INDICATIONS FOR SURGERY ALSO INCLUDED: PAIN. THE LINER/HEAD WAS REVISED AND A WOUND VAC WAS PLACED.

  Patient problems: Cellulitis; Erythema; Hematoma; Pain; Swelling/ Edema; Wound Dehiscence

  MAUDE report 16654669 ↗
• InjuryMar 24, 2023Migration; Migration

  IT WAS REPORTED THAT PATIENT BIPOLAR HAD MIGRATED AND THE HIP DISLOCATED FROM THE BIPOLAR. THE PATIENT WAS INFECTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16609221 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: IN 2012 PATIENT HAD INJECTIONS DUE TO DISCOMFORT. ON (B)(6) 2022 PATIENT UNDERWENT REVISION DUE TO DISCOMFORT AND DEVELOPED AN INFECTION AFTERWARD. ON (B)(6) /2022 MEDICAL RECORD NOTES THE PATIENT THEN UNDERWENT A RIGHT HIP SURGERY AND WAS FOUND TO HAVE INFECTION AND IS NOW ON IV ANTIBIOTICS. THE PATIENT HAS PAIN IN THE RIGHT HIP ON (B)(6) 2022 MEDICAL RECORDS NOTE THE PATIENT STARTED EXPERIENCING LEACHING OF METALS IN HER 10+-YEAR-OLD REPLACEMENT HIP JOINT INTO HER BODY AND CAUSING COGNITIVE AND PSYCHOLOGICAL CHANGES" ON (B)(6) 2022 LAB RESULTS ARE NOTED TO BE COBALT 5.4 ON (B)(6) 2022 NEUROLOGICAL VISIT TO ADDRESS ELEVATED BLOOD AND SERUM AND COBALT LEVELS AND THE POTENTIAL THAT IT COULD BE CAUSING COGNITIVE SYMPTOMS. IT WAS NOTED THAT IT WAS UNLIKELY THAT THE PATIENT¿S LEVEL TO CAUSE NEUROLOGICAL SYMPTOMS OR CONTRIBUTE TO THE PATIENT¿S MILD COGNITIVE IMPAIRMENT. DOI: ON (B)(6) 2010, DOR: ON (B)(6) 2022 , AFFECTED SITE: RIGHT HIP.

  Patient problems: Discomfort; Metal Related Pathology; Osteolysis; Pain; Unspecified Infection

  MAUDE report 16564193 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 PATIENT REPORTED A LOT OF BLOOD COMING FROM INCISION, THIS IS MOST LIKELY A HEMATOMA, PATIENT ADVISED TO APPLY PRESSURE DRESSING. ON (B)(6) 2021, THE PATIENT HAD A I&D WITH POLY LINER AND FEMORAL HEAD EXCHANGE TO ADDRESS INFECTED/SEPTIC TOTAL HIP. PATIENT IS CULTURE POSITIVE FOR MRSA. THE PATIENT PRESENTED WITH SWELLING, PAIN AND A FEVER. DEPUY POLY LINER WAS IMPLANTED ALONG WITH DEPUY CERAMIC FEMORAL HEAD. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED DUE TO VANCOMYCIN ACCUMULATION AND ACUTE KIDNEY INJURY DUE TO IV ANTIBIOTIC USE CAUSING ADVERSE EFFECTS. THE PATIENT WAS ALSO EXPERIENCING HALLUCINATIONS AND PERIPHERAL EDEMA. PATIENT STOPPED TAKING VANCOMYCIN AND WAS STARTED ON A DIFFERENT ANTIBIOTIC. DOI: (CUP AND STEM): (B)(6) 2020; DOI (HEAD AND LINER): (B)(6) 2021; RIGHT HIP.

  Patient problems: Fever; Fluid Discharge; Hematoma; Pain; Renal Impairment; Swelling/ Edema; Unspecified Infection; Unspecified Kidney or Urinary Problem

  MAUDE report 16451966 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE AROUND SUMMIT STEM A FEW DAYS AFTER INDEX ARTHOPLASTY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 16435155 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MOM PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM TOXIC HEAVY METAL RESULTING TO INJURY TO HER MUSCLE, TISSUE, SCAR TISSUE FORMATION, PAIN, METAL WEAR, LOSS OF ENJOYMENT OF LIFE, LIMITED ADL, EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2009. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Adhesion(s); Distress; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 16385969 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLAIM LETTER RECEIVED, CLAIM LETTER HAD NO ALLEGATION MENTIONED REGARDING PATIENT DEPUY HIP IMPLANT. DOI: (B)(6) 2009. DOR: (B)(6) 2020. AFFECTED SIDE LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Necrosis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16111394 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 15752270 ↗
• InjuryNov 4, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO FRACTURE AND LOOSENING AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 15728692 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2007; DOR: (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 15489298 ↗
• InjuryJul 19, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD PERIPROSTHETIC FRACTURE AND PATIENT FELL. IT WAS ALSO REPORTED THAT A NON-CEMENTED STEM WAS LOOSE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 15051315 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS, PPF, AND MEDICAL RECORD RECEIVED. PPF ALLEGES THAT AFTER THE FIRST REVISION, PATIENT HAD DISLOCATION WITH OPEN REDUCTION AND FRACTURE FEMUR. FRACTURE FEMUR WAS ALREADY REPORTED IN THE FIRST REVISION SINCE THE STEM IMPLANTED WAS NOT REMOVED. PATIENT CURRENTLY USE WALKER AND CAN ONLY PUT 50% OF WEIGHT ON LEGS, HAD NUMBNESS, PAIN, LIMITED MOVEMENT, AND DIFFICULTY WALKING. DOI: (B)(6) 2019. DOR: UNKNOWN. (LEFT HIP).

  Patient problems: Limb Fracture

  MAUDE report 14307969 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POST OP FEMORAL FRACTURE. PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 14110729 ↗
• InjuryJan 24, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A FRACTURED HIP THAT WAS FIXED WITH A SUMMIT STEM AND A BIPOLAR HEAD IN (B)(6). THE PATIENT SUFFERED A FALL AND BROKE HER GREATER TROCHANTER THAT CAUSED HER STEM TO SUBSIDE. THE DOCTOR DECIDED TO REMOVE THE CURRENT IMPLANTS AND REPLACED THEM WITH A 8¿ SOLUTION STEM AND A NEW BIPOLAR HEAD. HE ALSO CABLED THE TROCHANTER TO HELP REDUCE THE FRACTURE. THERE WAS LOOSENING OF THE FEMORAL COMPONENT (NON CEMENTED) NOTED AS WELL. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022 (LEFT HIP).

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration

  MAUDE report 13333155 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS HIP PAIN, WALKING DIFFICULTY, METALLOSIS, ELEVATED METAL IONS, ABDUCTOR DYSFUNCTION, PSEUDOTUMOR AND LIMB LENGTH INEQUALITY. OPERATIVE NOTE REPORTED UPON ENTRY TO THE FASCIA WE NOTED A BALD TROCHANTER WITH SIGNIFICANT METALLOSIS AND NO VIABLE MEDIUS TISSUES ATTACHED TO GREATER TROCHANTER. SCAR TISSUE AND METALLOSIS WERE DEBRIDED. ALL BLACK METALLOSIS TISSUE WAS DEBRIDED. DOI: (B)(6) 2006 , DOR: (B)(6) 2021, AFFECTED SITE: LEFT HIP.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Pain; Physical Asymmetry; Scar Tissue

  MAUDE report 12983027 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 12689318 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION, ASR XL, RIGHT HIP, REASON FOR REVISION: PAIN. DOI: (B)(6) 2006; DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Pain

  MAUDE report 12577067 ↗