SUMMIT POROCOAT 1570-01-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 10603295059363), received between Aug 10, 2017 and Feb 10, 2026 — classified as 163 injuries, 6 malfunctions.

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 169 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 THERE WAS FAILED PERIPROSTHETIC FRACTURE. THE STEM WAS REMOVED AND A COMPETITOR'S STEM WAS PLACED. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24304208 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE PRELIMINARY DATA REPORT WAS FROM THE ORTHOPEDIC RESEARCH FOUNDATION (ORTHOINDY), WHICH INCLUDES INFORMATION COLLECTED FROM SAINT VINCENT HOSPITAL AND HEALTH CARE CENTER, AS PART OF AN ON-GOING DATA USE AGREEMENT. THIS IS THE INTERIM VERSION OF THE DATA COLLECTION TEMPLATE (DCT), WHICH INCLUDES SAFETY-RELATED INFORMATION FOR THE VA-LCP PPFX SYSTEM. DURING THE REVIEW, DEPUY SYNTHES JOINT RECONSTRUCTION PRODUCTS WERE IDENTIFIED AS INVOLVED IN SOME OF THE COMPLICATIONS. A TOTAL OF 4 COMPLICATIONS INVOLVING JOINT RECONSTRUCTION PRODUCTS HAVE BEEN REPORTED ACROSS 3 PATIENTS. ALL COMPLICATIONS REQUIRED SURGICAL INTERVENTION. SUBJECT NUMBER (B)(6), 73-YEAR-OLD FEMALE. PATIENT EXPERIENCED ADVERSE TISSUE REACTION, ALLERGY/HYPERSENSITIVITY REACTION REQUIRING TROCHANTERIC DEBRIDEMENT. DATE OF ORIGINAL SURGERY WAS ON (B)(6) 2022.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 23525778 ↗
• InjuryApr 2, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT STEM WAS SUBSIDED, THEY REMOVED THE STEM AND WENT UP 2 SIZES. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 21754231 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED EXPLANTED / DUE TO INFECTION. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21656372 ↗
• InjuryMar 4, 2025Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF THE RIGHT TOTAL HIP ARTHROPLASTY, ACETABULAR COMPONENT DUE TO WORSENING PAIN AND CONSISTENT WITH METALLOSIS. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Limb Fracture; Necrosis; Pain

  MAUDE report 21514059 ↗
• InjuryFeb 24, 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 PER PROSTHETIC FRACTURE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 21446913 ↗
• InjuryNov 15, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED ON (B)(6) 2024 WHERE SHE HAD A SUMMIT PINNACLE CONSTRUCT IMPLANTED. THE PATIENT CAME IN FOR A FOLLOW UP AND THE X-RAY SHOWED THE STEM HAD SUBSIDED. THE DECISION WAS MADE WITH THE PATIENT AND SURGEON TO REVISE THEM STEM AND IMPLANT A RECLAIM MODULAR IMPLANT TO ACHIEVE DIAPHASYS FIXATION. THE SUMMIT STEM AND HIP BALL WERE EXPLANTED AND THE PINNACLE CUP AND LINER WERE KEPT IN SITU. NO SURGICAL DELAYS OR ADVERSE EVENTS TO REPORT OUTSIDE OF THE STEM SUBSIDENCE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20694065 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WERE THERE ANY ADVERSE CONSEQUENCES FOR THE PATIENT BECAUSE OF THE REPORTED EVENT? NO, AS STATED PREVIOUSLY, THE REVISION WAS DUE TO INFECTION, NOT IMPLANTS. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO, THE EVENT DID NOT OCCUR DURING SURGERY, SO THERE WAS NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20360070 ↗
• InjuryMay 9, 2024Adverse 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 APPROXIMATELY 6 WEEKS AGO BY SURGEON AT THE HOSPITAL. THE SURGEON BROUGHT THE PATENT INTO SURGERY AND EXPLANTED ALL OF HER IMPLANTS AND IMPLANTED A PROSTALAC CONSTRUCT. NO DELAYS, NO ADVERSE EVENTS TO REPORT. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19279374 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALL AT HER HOME AND IT CAUSED HER TO HAVE A PERI PROSTHETIC FRACTURE. HER HIP WAS REVISED TO A RECLAIM WITH NO ISSUES. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 18866149 ↗
• InjuryJan 9, 2024Fracture; Fracture

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SPECIFIC ALLEGATION AGAINST THE PINNACLE CUP.

  Patient problems: Insufficient Information

  MAUDE report 18474612 ↗
• InjuryJul 17, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO POST OP PAIN IN RIGHT THIGH A COUPLE WEEKS AFTER PRIMARY SURGERY. X RAY REVEALED STEM SUBSIDENCE AND A PERIPROSTHETIC FEMUR FRACTURE. SURGICAL DELAY WAS UNKNOWN. ACTIVITY LEVEL WAS YES. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture; Pain

  MAUDE report 17333270 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HIS HIP REPLACED ON (B)(6) 2023 AND BEGAN EXPERIENCING SOME DRAINING FROM THE WOUND SITE. IT WAS DECIDED TO DO A THOROUGH HIP I&D AND IMMEDIATE EXCHANGE OF ALL OF THE COMPONENTS. THE SUMMIT STEM, HIP BALL, PINNACLE CUP AND PINNACLE LINER WERE EXPLANTED AND NEW COMPONENTS WERE IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 16379185 ↗
• InjuryFeb 8, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE POTENTIALLY DUE TO FALL. LOOSENING WAS ALSO REPORTED AT BONE TO IMPLANT INTERFACE. DOI:(B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 16322303 ↗
• InjuryDec 29, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  AFTER A REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS THE COMPLICATION OF METAL ON METAL RIGHT TOTAL HIP REPLACEMENT RESULTING IN PAIN AND ELEVATED METAL IONS. THE OPERATIVE NOTE REPORTED SCAR TISSUE, OPAQUE FLUID, SYNOVITIS, AND DARK STAINING CONSISTENT WITH METALLOSIS. THERE WAS MINIMAL OXIDATIVE DEBRIS AT THE JUNCTION OF THE TRUNNION STEM.

  Patient problems: Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Synovitis

  MAUDE report 16069130 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS BROACHED TO A SIZE 5 SUMMIT, WHICH WAS STABLE. WHILE INSERTING STEM IMPLANT DID NOT MATCH STABILITY, SUBSIDED. NO COMPLICATIONS OCCURRED, SURGEON OPTED TO GO TO A SIZE 6 FEMORAL IMPLANT. THERE WAS 5 MINS OF SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15836923 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD RECEIVED. PATIENT WAS IMPLANTED WITH PINNACLE CUP AND METAL HEAD AND LINER LAST 2009 AND USING A DEPUY SUMMIT HIP SYSTEM. PATIENT EXPERIENCED PAIN, METALLOSIS, ELEVATED METAL ION, PSEUDOTUMORS, SWELLING, METAL DEBRIS, DIFFICULTY AMBULATION, STIFFNESS, BEEN CONSTIPATED SINCE THE SURGICAL PROCEDURE, DIFFICULTY TRANSFERRING AS WELL AS DOING ADLS, IMPAIRED ROM, IMPAIRED GAIT, BURSITIS, DECREASED LUMBAR MOBILITY, FLEXIBILITY, AND WEAKNESS. PATIENT HAD SIGNIFICANT BONE LOSS FROM TROCHANTERIC REGION OF FEMUR, AS WELL AS AROUND PORTIONS OF THE ACETABULUM. REVISION NOTES STATED THAT A BLACK GELATINOUS MATERIAL WAS ENCOUNTERED UPON ENTERING THE HIP JOINT AND ALVAL LESIONS WERE DEEP TO THE ACETABULAR IMPLANT. CUP, HEAD, AND LINER WERE REMOVED DURING THE FIRST REVISION OF THE LEFT HIP. LEFT DOI: (B)(6) 2009 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Necrosis; Osteolysis; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 15471315 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SINGLE STAGE DOUBLE SETUP REVISION DUE TO INFECTION. TOTAL HIP CONSTRUCT WAS REMOVED AND REPLACED WITH A NEW SUMMIT PINNACLE CONSTRUCT. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15292809 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE PAIN, INJURY, AND ELEVATED METAL ION LEVELS. UPDATE: (B)(6) 2015: LITIGATION ALLEGES PATIENT SUFFERS FROM DISCOMFORT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE AD (B)(6) 2022: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO THE RECEIPT OF ASR LITIGATION RECORD. PATIENT ALLEGES EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, AND ECONOMIC DAMAGES. ADDED PATIENT'S DOB, LAWYER, AND LAW FIRM. DOI: (B)(6) 2008. DOR: SCHEDULE: (B)(6) 2022. (LEFT HIP).

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Embolism/Embolus; Metal Related Pathology; Pain

  MAUDE report 15013021 ↗
• InjuryJul 14, 2022Degraded; Degraded

  LITIGATION PAPERS ALLEGE PAIN, INJURY, AND ELEVATED METAL ION LEVELS. UPDATE: 10/7/15 - LITIGATION ALLEGES PATIENT SUFFERS FROM DISCOMFORT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE AD 6 JUN 2022: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO THE RECEIPT OF ASR LITIGATION RECORD. PATIENT ALLEGES EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, AND ECONOMIC DAMAGES. ADDED PATIENT'S DOB, LAWYER, AND LAW FIRM. ADDED SURGEON AND REVISION HOSPITAL. DOI: (B)(6) 2006; DOR: (B)(6) 2021; (RIGHT HIP).

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Metal Related Pathology; Pain; Synovitis

  MAUDE report 15012842 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PERIPROSTHETIC FRACTURE. STEM WAS WELL FIXED, BUT EXPLANTED TO BYPASS FRACTURE. LOT NUMBERS UNABLE TO BE RETRIEVED. NOTHING FURTHER TO REPORT. THERE IS NO REPORTED LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Limb Fracture

  MAUDE report 14829025 ↗
• InjuryMay 10, 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. PATIENT CURRENTLY USE WALKER AND CAN ONLY PUT 50% OF WEIGHT ON LEGS, HAD NUMBNESS, PAIN, LIMITED MOVEMENT, AND DIFFICULTY WALKING. PATIENT FELL IN (B)(6) 2021 AND HAD FRACTURED FEMUR DUE TO DIFFICULTY IN WALKING, AND PAIN. NERVE PAIN IS MUCH WORSE AT NIGHT WHEN LAY DOWN. DOI: (B)(6) 2019 ; DOR: UNKNOWN; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Fall; Limb Fracture; Loss of Range of Motion; Numbness; Pain

  MAUDE report 14349308 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO SUSPECTED INFECTION. THA SURGERY COMPLETED APPROXIMATELY 6 WEEKS AGO. PATIENT BEGAN TO EXPERIENCE DRAINAGE AT HER WOUND SITE. REVISION SURGERY COMPLETED TO EXPLANT ALL IMPLANTS AND IMPLANT A PROSTALAC SPACER. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 14084359 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. HEAD/LINER WERE EXCHANGED ON (B)(6) 2022. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 13995597 ↗
• InjuryApr 1, 2022Degraded; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Degraded; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORD RECEIVED. PATIENT ALLEGES HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS, SUFFERED INJURY TO HIS MUSCLE AND TISSUE,SUFFERED ADDITIONAL SCAR TISSUE FORMATION, AND NOW HAS A HIP REPLACEMENT WITH DECREASED LONGEVITY. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE PINNACLE HIP REPLACEMENT, PLAINTIFF SUFFERED INJURIES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN, TISSUE DESTRUCTION, MUSCLE DESTRUCTION, METAL WEAR, METAL POISONING, LOSS OF ENJOYMENT OF LIFE, AND LIMITATION OF DAILY ACTIVITIES. 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; Arrhythmia; Discomfort; Dizziness; Dyspnea; Fall; Fatigue; Fibrosis; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Numbness; Pain; Physical Asymmetry; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 13977047 ↗