SUMMIT POROCOAT 1570-01-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295059325), received between Sep 1, 2017 and Mar 12, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Fitting Problem” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Osseointegration Problem

  IT WAS REPORTED THAT FEMORAL STEM WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24581106 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REDUCED THE HIP WHEN THE FEMUR BROKE, CAUSING SURGEON TO REMOVE THE FEMORAL STEM. SURGEON THEN CEMENTED A STEM INSTEAD. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 22311864 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 25 MAY 2022. AFTER REVIEW OF LITIGATION RECORDS, PLAINTIFF ALLEGES SEVERE PAIN AND 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. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cyst(s); Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Metal Related Pathology; Necrosis; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 14640255 ↗
• InjurySep 22, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  NEW ECM RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT (B)(4). PATIENT WAS REVISED TO ADDRESS A MALPOSITIONED CUP CAUSING WEAR OF THE LINER. CUP WAS NOTED TO HAVE BEEN PLACED IN 65 TO 70 DEGREES OF INCLINATION. UPDATE AD 16 APR 2019: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS VIA CD SHIPMENT LAST 04 APR 2019. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A FAILED TOTAL HIP ARTHROPLASTY WITH PAIN, POPPING AND CLICKING. THERE WAS SOME MARKED SYNOVITIS WHICH HAD A DARKISH STAIN TO IT. THE SURGEON SUSPECTED THAT THE PATIENT WAS HAVING PROBLEMS WITH METAL WEAR AND METAL DEBRIS. HOWEVER, UPON INSPECTION OF THE NECK TRUNNION, THERE WAS NO SIGNIFICANT WEAR ON THE NECK TRUNNION. THERE WERE A COUPLE OF MINOR SCRATCHES BUT IT WAS NOT CONSIDERED SIGNIFICANT. THERE WAS WEAR ON CUP AND IT WAS NOTED TO BE ASYMMETRICAL. THE STEM WAS NOTED TO BE STABLE AND THERE WAS NO EVIDENCE OF LOOSENING. POST-OPERATIVELY, THE PATIENT HAD ANEMIA DUE TO BLOOD LOSS. TWO UNITS WERE GIVEN TO THE PATIENT. LAB RESULTS TAKEN FROM (B)(6) 2015 SHOW ELEVATED COBALT AND CHROMIUM LEVELS. ADDED LAWYER, LAW FIRM, MEDICAL HISTORY, RELEVAN

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; No Code Available; Pain; Test Result

  MAUDE report 9102255 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION. ASR XL. LEFT HIP. REASON FOR REVISION: PAIN AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2019.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8479695 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR REVISION. ASR XL LEFT HIP. REASON FOR REVISION: PAIN. DOI: (B)(6) 2006 - DOR: (B)(6) 2019. UPDATE 06 MAR 2019. REVISION CONFIRMATION FORM RECEIVED. IT WAS NOTED THAT RADIOLOGICAL INVESTIGATIONS DONE BY THE PHYSICIAN WERE SUGGESTIVE OF ALVAL AND LOOSENING OF THE ACETABULAR COMPONENT. SURGEON ALSO NOTES THAT THE PATIENT HAS RISKY LEVELS OF METAL IONS IN BLOOD, BUT NO LAB RESULTS WERE PROVIDED.

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8460394 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2011; DOR: NONE REPORTED; (LEFT HIP). SEE (B)(4) FOR RIGHT HIP.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8256583 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS BEFORE FIRST REVISION.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8222123 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE AFTER HIS SURGERY, PATIENT BEGAN EXPERIENCING PAIN THAT CONTINUES TO DATE. IT IS FURTHER ALLEGED PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING, BUT NOT LIMITED TO, PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, HIGH LEVELS OF TOXIC METAL IN HIS BLOOD STREAM. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Pain; Test Result

  MAUDE report 8112212 ↗
• InjuryNov 9, 2018Loose or Intermittent Connection; Fitting Problem; Unintended Movement; Loose or Intermittent Connection; Fitting Problem; Unintended Movement

  IT WAS REPORTED THAT THE FIRST HIP REVISION WAS DUE TO PAIN CAUSED BY A FRACTURE OF THE GREATER TROCHANTER AND SUBSIDENCE OF THE FEMORAL COMPONENT. ONLY THE FEMORAL COMPONENT AND FEMORAL HEAD WERE REVISED.

  Patient problems: No Code Available; Pain

  MAUDE report 8055869 ↗
• InjuryJun 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD THA ON (B)(6). PATIENT FELL DOWN GOING TO BATHROOM AND BROKE FEMUR ON SAME LEG. TOOK PATIENT TO SURGERY ON (B)(6). REMOVED HIP STEM, FIXED FEMUR FRACTURE, REIMPLANTED SAME TOTAL HIP IMPLANTS. SECOND SURGERY WENT ACCORDING TO PLAN.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 7633268 ↗
• InjurySep 1, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AND SUFFERING, ADDITIONAL UNFORESEEN SURGERIES, AND METALLOSIS. PATIENT IS NOT SCHEDULED FOR AN EXPLANTATION, BUT IS REGULARLY BEING MONITORED FOR CHROMIUM/COBALT IONS AND HIP FRACTION. DOI: (B)(6) 2008 - DOR: NONE REPORTED (RIGHT HIP); PATIENT IS A RESIDENT OF (B)(6). UPDATE: 12 SEPT 2014 - DER RCVD. UPDATED DOR, PATIENT AGE, HEIGHT AND WEIGHT, HOSPITAL, SALES REP INFORMATION AND ADDED SLEEVE. CUP REPORTED HOWEVER CONFIRMATION ON DER THAT REMAINS INSITU. REASON(S) FOR REVISION : ELEVATED COCR LEVELS UPDATE AUG 4, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS PAINFUL PROSTHESIS AND ELEVATED METAL LEVELS. REVISION NOTES REPORTED BROWNISH-STAINED BURSAL FLUID, PSEUDOCAPSULE, AND BURNISHING ON THE HEAD. THERE WERE NO LABORATORY RESULTS PROVIDED FOR THE METAL IONS. ADDED STEM TO THE COMPLAINT DUE TO ALLEGED ELEVATED METAL IONS. THIS COMPLAINT WAS UPDATED ON AUG 17, 2017.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 6837596 ↗