SUMMIT POROCOAT 1570-11-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 10603295060062), received between Jan 26, 2015 and Feb 10, 2026 — classified as 168 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (31 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 173 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT PRIMARY SURGERY VIA THA WITH THE PRODUCT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, A PERI-STEM FRACTURE WAS FOUND. ON (B)(6) 2026, THE PATIENT UNDERWENT SURGERY. THE STEM WAS NOT LOOSE, AND THE SURGEON RECONSTRUCTED USING A PLATE FROM ANOTHER COMPANY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REPLACEMENT IMPLANT IS RETAINED AND NOT REMOVAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Limb Fracture

  MAUDE report 24303721 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL DOWN AND HAD A PERI PROSTHETIC FRACTURE. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23018897 ↗
• InjuryAug 28, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: PATIENT WAS REVISED DUE TO DEGENERATIVE PAIN, SORENESS, DIFFICULTY WALKING, AND SIGNIFICANTLY ELEVATED COBALT AND CHROMIUM LEVELS WITH A LARGE PSEUDOTUMOR AND ABDUCTOR AND SOFT TISSUE COMPROMISE INCLUDING NECROSIS. DOI: (B)(6) 2011. DOR: (B)(6) 2022. LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Necrosis; Pain; Swelling/ Edema; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Tissue Injury

  MAUDE report 20086002 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO DELAY.

  Patient problems: Pain

  MAUDE report 19353033 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. THERE WAS NO LOOSENING. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 19020628 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6); STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PERIPROSTHETIC FRACTURE. DATE OF IMPLANT: (B)(6) 2023; DATE OF REVISION: (B)(6) 2024; (LEFT HIP). TREATMENT: STEM AND HEAD REVISED.

  Patient problems: Limb Fracture

  MAUDE report 18888558 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: 007-16755. STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL PERIPROSTHETIC FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: 15 JAN 2024. (LEFT HIP). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 18570420 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PERIPROSTHETIC FRACTURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: 03 JAN 2024. (LEFT HIP). TREATMENT: STEM AND HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration; Limb Fracture; Osteolysis; Unspecified Infection; Unspecified Musculoskeletal problem

  MAUDE report 18544136 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PERIPROSTHETIC FRACTURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: 03 JAN 2024. (LEFT HIP). TREATMENT: STEM AND HEAD WERE REVISED. WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Limb Fracture

  MAUDE report 18544099 ↗
• InjuryJan 8, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT CAME BACK IN WITH A SUBSIDED SUMMIT STEM IMPLANTED ON (B)(6) 2022. UPON OPENING THE JOINT, A FRACTURE WAS FOUND. THE STEM AND HEAD WERE PULLED, THE FEMUR WAS CABLED AND A FEMORAL STRUT WAS PLACED. ONCE THE FRACTURE WAS REPAIRED, THE SURGEON IMPLANTED A RECLAIM MONOBLOCK STEM. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 18463670 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED: THIS WAS AN INTRAOPERATIVE FX WHICH OCCURRED AT TIME OF TRIALING OF THE PROSTHESIS. ORIF WAS ACCOMPLISHED WITH TWO CERCLAGE WIRES WHICH WILL NOT BE REMOVED.

  Patient problems: Limb Fracture

  MAUDE report 18382739 ↗
• MalfunctionNov 28, 2023Fracture; Device Contaminated During Manufacture or Shipping; Fracture; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO CONSEQUENCES FOR THE PATIENT AS THE IMPLANT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18216654 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED RIGHT HIP. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18055985 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES REVIEWED. ON (B)(6) 2023, THE PATIENT HAD A REVISION RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO THE PROTRUSION OF THE ACETABULAR CUP INTO THE PELVIS WITH POSTERIOR COLUMN AND ISCHIAL FRACTURE. THE PATIENT ALSO HAD AN OPEN REDUCTION AND INTERNAL FIXATION, POSTERIOR COLUMN FRACTURE USING 3.5MM PELVIC RECONSTRUCTION PLATES, AND BONE GRAFT. THE PATIENT ALSO REPORTED HAVING PAIN. THE SURGEON OBSERVED A POSTERIOR COLUMN FRACTURE, A LARGE DEFECT IN THE POSTERIOR SUPERIOR WALL AND COLUMN. THE FEMORAL STEM WAS REVISED IN ORDER TO PROVIDE BETTER EXPOSURE DURING THE ACETABULAR RECONSTRUCTION. THE SURGEON OBSERVED A LARGE AREA OF HEALING HEMATOMA IN THE GLUTEUS AND ALSO ECCHYMOSIS OVER HER ANTERIOR KNEE WHICH THE SURGEON CORRELATED WITH A FALL. DEPUY COMPONENTS, INCLUDING DEPUY PROTRUSION CAGE AND CEMENT, WERE USED DURING THIS PROCEDURE.

  Patient problems: Fall; Hematoma; Limb Fracture; Pain

  MAUDE report 17450925 ↗
• InjuryJul 26, 2023Degraded; Degraded

  METAL ON METAL HIP MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT THA WITH METALLOSIS AND PSEUDOTUMOR RESULTING TO HIP PAIN AND ELEVATED METAL IONS. MRI CONFIRMED PSEUDOTUMOR. SLIGHT ELEVATED CELL COUNTS AND SED RATE. ASPIRATION CONFIRMED INFECTION. OPERATIVE NOTE REPORTED SCARRED EXTERNAL ROTATOR AND PURULENT APPEARING FLUID OBVIOUS BROWNISH PSEUDOTUMOR. THERE WAS CORROSION ON THE TRUNNION HOWEVER, STEM WAS WELL FIXED. THERE WAS 2 SCREWS 1 EASILY REMOVE AND THE OTHER ONE IS VERY DIFFICULT TO REMOVE. THERE WAS ACETABULAR MEMBRANE IN THE LINER AND SOME SMALL CAVITARY DEFECTS. DOI: (B)(6), 2007; DOR: (B)(6), 2023; RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17396232 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO EARLY INFECTION. THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM AN IMMEDIATE EXCHANGE OF IMPLANTS WITH A THOROUGH WASHOUT OF THE HIP. THE SURGEON EXPLANTED ALL THE IMPLANTS AND WASHED THE WOUND OF ANY POTENTIAL INFECTION. THE HIP WAS THEN PREPPED FOR NEW IMPLANTS AND THEY WERE OPENED AND INSERTED. A REDUCTION OF THE HIP WAS PERFORMED AND FOUND TO BE STABLE. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17224400 ↗
• InjuryJun 27, 2023Adverse 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, CLINICAL VISIT REPORTED CONSISTENT MOM DISEASE , PAIN AND LIMITED ADL, DIFFICULTY WALKING AND MUSCLE WEAKNESS AFTER FIRST REVISION OF THE LEFT HIP. ON 07/14/2020 COBALT 6.7 MCG/L CHROMIUM 34.6 MCG/L ON (B)(6)2021 LEFT HIP MRI NOTED A LARGE FLUID COLLECTION ALONG WITH TEARS OF THE LEFT GLUTEUS MEDIUS AND MINIMUS TENDON INSERTIONS. ON 02/12/2021 LAB RESULTS: CHROMIUM 24.3 UG/L. ON (B)(6)2022 RADIOGRAPHS OF THE LEFT HIP ARE REPORTED TO SHOW THE ACETABULAR COMPONENT IS A LITTLE VERTICAL IN ORIENTATION. THE PATIENT NOTED THAT THEIR HIP FEELS UNSTABLE. IT WAS NOTED THAT ON (B)(6)2022 THE PATIENT¿S HIP DISLOCATED AND THEY NEEDED A CLOSED REDUCTION. ON 05/02/2022 LAB VALUES NOTED COBALT WAS 3.1 AND CHROMIUM PLASMA WAS 33.5 WITH NO UNIT OF MEASUREMENT PROVIDED. ON (B)(6)2022 THE PATIENT LEFT TOTAL HIP REVISION TO ADDRESS INSTABILITY, PAIN, AND ABDUCTOR WEAKNESS LEFT HIP. PRIOR TO SURGERY, THE PATIENT REPORTED THAT THEY FEEL POPPING AND HAD DISLOCATED. DURING THIS PROCEDURE, THE SURGEON OBSERVED LARGE JOINT EFFUSION, METAL DEBRIS AS EVIDENCED BY BLACK SYNOVIAL TISSUE. THE PATIENT¿S ABDUCTOR MUSCLES WERE NOTED TO SIGNIFIC

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Joint Laxity; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17208273 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16919188 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED AND STATED THE FOLLOWING: PFS ALLEGES HIP PAIN, ELEVATED METAL IONS, METALLOSIS, ANXIETY AND DEPRESSION. DOI: (B)(6) 2007; DOR: UNKNOWN; LEFT HIP.

  Patient problems: Anxiety; Deformity/ Disfigurement; Depression; Discomfort; Distress; Foreign Body Reaction; Pain

  MAUDE report 16824483 ↗
• InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO DRAINING OUT OF THE RIGHT HIP WOUND 3 WEEKS AFTER SURGERY. THIS PATIENT HAD BILATERAL HIP REPLACEMENTS ON (B)(6) 2022 . THE SURGEON DID A I&D WITH AN EXPLANT AND IMMEDIATE EXCHANGE OF IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 15182913 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION COMPLAINT RECEIVED AD 27 JUN 2022. LITIGATION RECORDS ALLEGES PAIN, DISCOMFORT, INCREASED METAL LEVEL IN BLOOD INCLUDING COBALT AND CHROMIUM, INJURY, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT AND ECONOMIC CHANGES. DOI: (B)(6) 2007, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Cyst(s); Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15005711 ↗
• InjuryMar 8, 2022Osseointegration Problem; Migration; Osseointegration Problem; Migration

  REVISION COMPLETED DUE TO SUMMIT STEM SUBSIDING OR SETTLING. THERE WAS LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. NO FRACTURE EVIDENT. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13695191 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORD RECEIVED. PATIENT ALLEGES ELEVATED METAL ION RESULTING IN INJURY, SUFFERED ADDITIONAL SCAR TISSUE FORMATION, PAIN, TISSUE DESTRUCTION, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE, LIMITATION OF DAILY ACTIVITIES, EMOTIONAL TRAUMA AND DISTRESS, AND PHYSICAL DISABILITIES. DOI: (B)(6) 2008; DOR: (B)(6) 2021; UNK HIP.

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

  MAUDE report 13620858 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. OPERATIVE NOTES IT INDICATES SOME SIGNIFICANTLY ELEVATED METAL ION LEVEL AND SOME NEUROLOGIC SYMPTOMS. OPERATIVE NOTES SHOWS THAT ACETABULAR SHELL SEEMED QUITE ANTEVERTED. DOI: (B)(6) 2009. DOR: (B)(6) 2019, LEFT HIP.

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

  MAUDE report 13313820 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR XL REVISION RECEIVED. PFS HAS NO ALLEGATION REPORTED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO METALLOSIS, PAIN, LOSS OF FUNCTIONAL ABILITY AND INCREASING METAL ION LEVELS HOWEVER NO LABORATORY RESULTS REPORTED. OPERATIVE NOTES UPON OPENING THE BURSA THERE WAS GRAY FLUID FOUND. FEMORAL BALL WAS BROUGHT INTO THE WOUND AND THERE WAS A VERY SMALL NOTCH A COUPLE MILLIMETERS DEEP AND THE TRUNNION WHERE THE BAND IMPINGING ON THE VERY SHARP EDGE OF THE ASR SOCKET. DOI: (B)(6) 2009; DOR: (B)(6) 2017 ; RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Loss of Range of Motion; Swelling/ Edema; Unspecified Musculoskeletal problem

  MAUDE report 13076100 ↗