SUMMIT POROCOAT 1570-11-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 204 adverse event reports that list this exact device (DI 10603295060079), received between Aug 26, 2016 and Apr 7, 2026 — classified as 1 death, 200 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (33 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 204 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ITEMS WERE EXPLANTED DUE TO FRACTURE. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Limb Fracture

  MAUDE report 24802548 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FRACTURE IN POST OP AND WAS BROUGHT BACK TO THE OR WHERE THE CURRENT PRESSFIT SUMMIT STEM WAS REMOVED AND A CEMENTED SUMMIT STEM REPLACED IT FOR A MORE STABLE CONSTRUCT FOR THE FRACTURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 24143946 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH REMOVAL OF HIP DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22481199 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ASR REVISION OF THE CUP, STEM, HEAD, AND SLEEVE. DUE TO THE AMBIGUOUS LANGUAGE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY ATTRIBUTE THE PAIN, DAMAGES, AND DISFIGUREMENT TO ONLY THE CUP AND HEAD. THEREFORE, THE CUP, STEM, HEAD, AND SLEEVE WILL BE REPORTED DUE TO THE REPORTED UNSPECIFIED PAIN, DAMAGES, AND DISFIGUREMENT. ASR XL. RIGHT HIP. REASON FOR REVISION: UNKNOWN/NA. DOI: UNKNOWN. DOR: UNKNOWN.

  Patient problems: Pain

  MAUDE report 21651262 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR CLAIM RECEIVED. THERE ARE NO ALLEGATIONS AND THERE IS LIMITED INFORMATION AVAILABLE. AS OF THE MOMENT, THERE ARE NO RECORDS RECEIVED AND NO KNOWN LAWSUIT FILED. DOI: (B)(6) 2007 - DOR: NOT REVISED (UNKNOWN HIP) ADDITIONAL EVENT INFORMATION: REVISION FOR PAIN AND LABORATORY RESULT SHOWS ELEVATED COBALT AND CHROMIUM LEVEL.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain

  MAUDE report 20517546 ↗
• MalfunctionOct 15, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO C. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. INNER PLASTIC PACKAGE WAS CRACKED. D. PLEASE CONFIRM IF PRODUCT RECEIVED WITH A BREACH IN THE INTEGRITY OF THE SEAL? SEAL OF PACKAGE AROUND IMPLANT WAS NOT COMPROMISED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451701 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2024 DUE TO A PERIPROSTHETIC PROXIMAL FEMUR FRACTURE AFTER A FALL. PATIENT WAS REVISED TO A REVISION HIP STEM. INITIAL IMPLANT DATE WAS (B)(6) 2016

  Patient problems: Fall; Limb Fracture

  MAUDE report 20352876 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE ITEMS WERE REMOVED, DUE TO INFECTION OF PATIENT. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19468023 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PERIPROSTHETIC HIP FRACTURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: (B)(6) 2024. (RIGHT HIP). TREATMENT: HEAD AND STEM WERE REVISED.

  Patient problems: Limb Fracture

  MAUDE report 19215217 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT GOT A TOTAL HIP REPLACEMENT 11 DAYS AGO AND FELL, FRACTURING HER FEMUR OVER HER NEW PROSTHESIS. SURGEON WANTED TO PULL OUT THE STEM AND HEAD AND KEEP THE ORIGINAL CUP. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 19191087 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SHOWING SIGNS OF INFECTION, SO THE SURGEON FELT THEY WOULD BENEFIT FROM AN IMMEDIATE EXCHANGE OF IMPLANTS WITH A THOROUGH WASHOUT. IMPLANTS WERE REMOVED AND THE HIP WAS CLEANED. PRIMARY COMPONENTS WERE PREPPED AND IMPLANTED AND THE HIP WAS FOUND TO BE STABLE. . NO ADVERSE EVENTS OR DELAYS TOOK PLACE. DOI: (B)(6) 2023. DOR: (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 18443359 ↗
• InjuryOct 24, 2023Naturally Worn; Naturally Worn

  PATIENT ALLEGES METALLOSIS AND LAB WORKS CONFIRMS MARS. MRI CONFIRMS AREAS OF FLUIDS AND PARTICLES WHICH WILL NEED DEBRIDEMENT AND OTHER SIDE EFFECTS OF THE PRODUCTS REPLACED. ADDITIONAL EVENT INFORMATION: AFTER REVIEW OF MEDICAL RECORDS, OPERATIVE NOTES REPORTED OF METALLOSIS LESIONS WITH TYPICAL NECROTIC TYPE TISSUE AND A VERY TYPICAL MUCOPURULENT TYPE FLUID. THE CUP WAS SLIGHTLY LATERIZED AND THERE WAS SOME METAL TRUNNION WEAR. CLINIC VISIT REPORTED OF PAIN. DOI: (B)(6) 2010. DOR: (B)(6) 2023. LEFT HIP.

  Patient problems: Foreign Body Reaction; Necrosis; Pain; Swelling/ Edema

  MAUDE report 17995424 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, AND DIFFICULTY WALKING, AND PERFORMING ACTIVITIES OF DAILY LIVING. DOI: (B)(6) 2007 - DOR: NONE REPORTED (RIGHT HIP). UPDATE 12/26/2012- PFS AND MEDICAL RECORDS WERE RECEIVED FROM LEGAL. PART/LOT INFORMATION WAS IDENTIFIED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. AGE AND MIDDLE INITIAL ADDED. UPDATE AD 29 JUNE 2018: WPC 14940-2012 HAS BEEN RE-OPENED UNDER (B)(64 DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF HAS NO ALLEGATION AND REVISION REPORTED. A LAWYER WAS ADDED. THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY THE LEFT HIP WAS CAPTURED UNDER (B)(4). DOI: (B)(6) 2007. DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 17965781 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DEEP INFECTION. PATIENT UNDERWENT A WASHOUT AND IMMEDIATE EXCHANGE. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17807424 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DEEP INFECTION. DID A WASHOUT AND IMMEDIATE EXCHANGE. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17740892 ↗
• InjuryAug 25, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: ON (B)(6) 2021, THE PATIENT UNDERWENT A LEFT HIP REVISION FOR ELEVATED COBALT AND CHROMIUM LEVELS AS CAPTURED IN THIS CURRENT PC. DURING THE REVISION, A PINNACLE DUAL MOBILITY LINER, BI-MENTUM PE LINER, AND ARTICUL/EZE FEMORAL HEAD WERE PLACED. ON (B)(6) 2021, THE PATIENT VISITS THE EMERGENCY DEPARTMENT AFTER FALLING AND HAS KNEE PAIN AND LEFT LOWER EXTREMITY WEAKNESS. SHE IS ALSO CONCERNED ABOUT PUS AT THE TOP OF HER INCISION SITE. THE PHYSICIAN DETERMINED THERE WAS MINIMAL WOUND DEHISCENCE AND X-RAYS WERE CLEAR, SO NO INTERVENTION WAS REQUIRED. ON (B)(6) 2021, THE PATIENT VISITS THE EMERGENCY DEPARTMENT FOR LEFT HIP PAIN AFTER FALLING 3 TIMES DUE TO HER LEFT KNEE BUCKLING. NO INTERVENTION WAS PERFORMED ON (B)(6) 2022, THE PATIENT HAS A CLINIC VISIT WITH COMPLAINTS OF REDNESS AND DRAINAGE FROM HER LEFT HIP INCISION. NO INDICATION OF TREATMENT IF THERE WAS ANY. ON (B)(6) 2022, CONTINUES TO COMPLAIN OF LEFT KNEE PAIN AND INSTABILITY AS WELL AS RIB PAIN ¿ ALL UNRELATED TO THE LEFT HIP REVISION. ON (B)(6) 2022, THE PATIENT HAS A CLINIC VISIT FOR FOUR FALLS SINCE HER LEFT REVISION. SHE HAS INCREASING LEFT KNEE PAIN AND FEELINGS OF BUCKLING AND CATCHING ¿

  Patient problems: Erythema; Fall; Fatigue; Fluid Discharge; Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 17623787 ↗
• InjuryAug 24, 2023Naturally Worn; Naturally Worn

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2024, THE PATIENT HAS PAIN, AND SHE FEELS THE LEFT HIP IS "PUFFY." THE PATIENT IS POSITIVE FOR BACILLUS NON ANTHRACIS AND METAL LEVELS OF BOTH CO/CR REMAIN ABOVE 10. THERE IS PLAN FOR A REVISION SECONDARY TO INFECTION WITH PLACEMENT OF AN ANTIBIOTIC SPACER. ALSO THE ENTIRE CONSTRUCT IS PLANNED TO BE REMOVED IN ORDER TO ALSO REMOVE "THE METAL GENERATOR IN HER HIP POSSIBLY FROM DAMAGED TRUNNION." THERE ARE NO REVISION NOTES PROVIDED AT THIS TIME. THERE IS XRAY NOTATION OF A HEALED DISTAL FEMORAL FRACTURE THOUGH PATIENT HAS A HISTORY OF A MOTOR VEHICLE ACCIDENT THAT CAUSED THIS PRIOR TO THE ORIGINAL L THA.

  Patient problems: Ambulation or Postural Difficulties; Cellulitis; Depression; Discomfort; Embolism/Embolus; Fatigue; Foreign Body Reaction; Hematoma; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Nausea; Numbness; Physical Asymmetry; Swelling/ Edema; Unspecified Infection; Vomiting

  MAUDE report 17611788 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED DUE TO PAIN. UPDATE REC'D 5/25/2016: LITIGATION RECEIVED. LITIGATION ALSO ALLEGES DISCOMFORT, METALLOSIS, AND ELEVATED METAL IONS. THE STEM IS BEING ADDED TO THE COMPLAINT. A DOI WAS PROVIDED. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2016. UPDATE AD (B)(6) 2018: COM-(B)(4) HAS BEEN RE-OPENED UNDER PC-(B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. PPF ALLEGES OF PSEUDOTUMOR, FRACTURE BONE, ABDUCTOR MUSCLE REPAIR, INFECTION REQUIRING IV ANTIBIOTIC AND LOOSENING OF STEM. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT HIP METAL-ON-METAL IMPLANT. STEM, HEAD AND CUP WAS UPDATED. LINER WAS ADDED DUE TO ALLEGES INFECTION. DATE OF REVISION IN RIGHT HIP WAS UPDATED TO (B)(6) 2015. REVISION IN LEFT HIP WAS CAPTURED UNDER PC-(B)(4).

  Patient problems: Bone Fracture(s); Discomfort; Inadequate Osseointegration; Metal Related Pathology; Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 17441500 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION OF THE RIGHT HIP IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17398260 ↗
• InjuryApr 13, 2023Degraded; Degraded

  LITIGATION RECORDS RECEIVED. AFTER REVIEW, PATIENT WAS REVISED DUE TO THE FOLLOWING REASONS : SUFFERED HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RELEASED BY THE PINNACLE SYSTEM RESULTING IN INJURY. MOREOVER, PATIENT EXPERIENCE INCREASING PAIN, DISCOMFORT, AND SIGNIFICANT MEMORY LOSS. ON (B)(6), 2020, A COBALT CHROMIUM METAL ION TEST SHOWED INCREASED METAL ION LEVELS TO DIAGNOSE COBALT TOXICITY. ON (B)(6) 2020, PLAINTIFF LEARNED HIS METAL ION LEVELS HAD INCREASED AND AN MRI REVEALED FLUID DISTENTION OF THE PSEUDO-CAPSULE AND OSTEOLYSIS OF THE TROCHANTER OF THE RIGHT HIP. HIS MEMORY ISSUES WERE WORSENING.

  Patient problems: Discomfort; Fibrosis; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Memory Loss/Impairment; Metal Related Pathology; Necrosis; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16739244 ↗
• InjuryMar 20, 2023Migration; Migration

  CLINICAL ADVERSE EVENT RECEIVED FOR GREATER TROCHANTER FX WITH DISPLACEMENT. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT HIP). TREATMENT: NONE.

  Patient problems: Limb Fracture

  MAUDE report 16571972 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REPORT, ADVERSE LOCAL TISSUE REACTION.

  Patient problems: Ambulation or Postural Difficulties; Bone Notching; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Limb Fracture; Metal Related Pathology; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 16564359 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED FOR INFECTION. ALL COMPONENTS REMOVED, PROSTOLAC WAS IMPLANTED. NO SURGICAL DELAY, NOTHING FURTHER TO REPORT. NO LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16501694 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION COMPLAINT RECEIVED AD 17 OCT 2022. PATIENT WAS REVISED WAS DUE TO PAIN, DISCOMFORT, INCREASED METAL LEVELS IN BLOOD INCLUDING COBALT AND CHROMIUM, PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT AND ECONOMIC DAMAGES. DOI: (B)(6) 2007; DOR: (B)(6) 2022; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Deformity/ Disfigurement; Depression; Discomfort; Distress; Metal Related Pathology; Pain

  MAUDE report 15707617 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORDS AND STICKER SHEET RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAIN, DYSFUNCTION, LIMITED ADL, METALLOSIS AND CHRONIC PROSTHETIC JOINT INFECTION. OPERATIVE NOTE REPORTED 150 CC PURULENCE FLUID SIGNIFICANT INFECTIOUS HYPERTROPHIC SYNOVIUM, ANTERIOR ACETABULAR BONE LOSS AND SOFT TISSUES WERE INFLAMED. THERE WERE SCAR TISSUE AROUND THE STEM HOWEVER WELL FIXED. DUE TO COMPLEXITY OF THE SURGERY IT WAS RESULTED TO INCREASED OPERATIVE TIME AND EFFORT. DOI: (B)(6) 2008; DOR: (B)(6) 2022; LEFT HIP.

  Patient problems: Adhesion(s); Extraskeletal ossification; Foreign Body Reaction; Inflammation; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15639256 ↗