SUMMIT POROCOAT 1570-11-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295060031), received between Jul 18, 2017 and Sep 30, 2022 — classified as 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (5 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  RECEIVED SUMMIT STEM WITH WHAT APPEARS TO BE A HAIR SEALED BETWEEN THE BOX AND THE CELLOPHANE WRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518813 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15066420 ↗
• InjuryJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE SUMMIT STEM IMPLANTED BY SURGEON IN (B)(6) 2019 BROKE. REMOVED BY ANOTHER SURGEON. DOI: (B)(6) 2019; DOE: (B)(6) 2021; AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13225793 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FEMUR FRACTURE. NO ADDITIONAL INFORMATION.

  Patient problems: Limb Fracture

  MAUDE report 12659686 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. PRODUCT WAS USED WITH COMPETITOR. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11279561 ↗
• InjuryMar 25, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LINER AND HEAD WERE REPLACED DUE TO INCREASED METAL ION LEVELS. RANGE OF MOTION: PATIENT HAS NO PAIN WITH ROTATIONAL MOVEMENTS. THIS REPLACEMENT WAS INITIATED AS A PROPHYLACTIC MEASURE. DOI: (B)(6) 2010. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9878529 ↗
• InjuryFeb 12, 2020Corroded; Corroded

  DOI:(B)(6) 2006 DOR: NONE REPORTED (UNK SIDE). UPDATE: 8/31/2012 LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT HAD SEVERE PAIN AND DISCOMFORT. LITIGATION PENDING THAT THE PATIENT HAD PINNACLE PRODUCTS NOT ASR. (RIGHT HIP). UPDATE 1/14/2013 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 29 JUN 2018: WPC 3278-2012 HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF ALLEGES METAL WEAR METALLOSIS. ADDED LAWYER IN ASSOCIATED CONTACT, SURGEON, ACCOUNT NAME, LAW FIRM, UPDATED DATE OF REVISION, UPDATED PATIENT HARM AND MANUFACTURED DATE IN PRODUCT DETAILS. CORRECTED PATIENT IDENTIFIER. DOI: (B)(6) 2006 - DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; No Code Available; Pain; Pocket Erosion; Tissue Damage

  MAUDE report 9702233 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORDS RECEIVED ALLEGING PAIN, SUFFERING, INJURY, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, PARTIAL OR COMPLETE LOSS OF MOBILITY, AND LOSS OF RANGE OF MOTION. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PFS ALLEGED CLICKING. AFTER REVIEW OF MEDICAL RECORDS NO REVISION NOTES REPORTED. LAB RESULT FOR ELEVATED METAL IONS WERE ELEVATED. ADDED MEDICAL HISTORY, LABORATORY RESULT AND HEIGHT. DOI: (B)(6) 2010, DOR: NONE REPORTED, RIGHT HIP.

  Patient problems: Deformity/ Disfigurement; Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 9617514 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORDS RECEIVED ALLEGING PAIN, SUFFERING, INJURY, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, PARTIAL OR COMPLETE LOSS OF MOBILITY, AND LOSS OF RANGE OF MOTION. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PFS ALLEGED CLICKING. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED ELEVATED METIOL IONS. OPERATIVE NOTES INDICATED SMALL AMOUNT OF FLUID AND SAW NO TISSUE DAMAGE. UPON REMOVING THE METAL HEAD, NOTED SIGNIFICANT TRUNNIONOSIS. ADDED MEDICAL HISTORY, LABORATORY RESULT, HEIGHT AND WEIGHT OF PATIENT. DOI: (B)(6) 2009; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Foreign Body Reaction; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 9617421 ↗
• InjuryJan 10, 2020Loss of Osseointegration; Osseointegration Problem; Migration; Loss of Osseointegration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE STEM SUBSIDED AND LOOSENED AT THE BONE TO IMPLANT INTERFACE. THE STEM WAS REMOVED AND PUT IN A CORAIL REVISION. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9578302 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED TO ADDRESS FAILED LEFT THR, COMPONENT RECALL, METALLOSIS REACTION AND LOOSENING RESULTING TO PAIN AND ELEVATED METAL LEVELS IN THE BLOODSTREAM. OPERATIVE NOTES REPORTED SLIGHTLY BLOODY FLUID, METALLOSIS AND ACETABULAR COMPONENT WAS GROSSLY LOOSE AND LARGE AMOUNT OF METALLIC DEBRIS. DOI: (B)(6) 2008; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Edema; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; Pain; Test Result

  MAUDE report 9565336 ↗
• InjuryDec 18, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENTS STEM WAS LOOSE DUE TO A FALL AND FRACTURING HER PROXIMAL FEMUR. THE SURGEON DECIDED TO REMOVE THE STEM AND REPLACE WITH A LONGER AML STEM. AFTER IMPLANTING THE STEM HE REPLACED WITH AN APPROPRIATE SIZE HEAD AND TROCHANTERIC CLAW PLATE. NO ONE INDICATED A PROBLEM WITH THE IMPLANTS. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; No Code Available

  MAUDE report 9488884 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS A SURGICAL DELAY OF 5 MINUTES BECAUSE IT TOOK TIME TO UNTHREAD BROKEN PIECE OUT OF THE CENTER HOLE OF THE CUP TO ATTEMPT TO THREAD ANOTHER HANDLE INTO CUP FOR REMOVAL.

  Patient problems: No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 8937502 ↗
• InjuryMay 10, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT WAS A RECURRENT DISLOCATOR. IT WAS ALSO INDICATED THAT THE FEMORAL STEM WAS LOOSE AT THE BONE TO IMPLANT INTERFACE AND REVISED. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8599138 ↗
• InjuryMay 2, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE AROUND A SUMMIT STEM. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8573288 ↗
• InjuryApr 16, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: Test Result

  MAUDE report 8518714 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS AN IMPROPERLY-SEATED LINER, REACTIVE TISSUE, AND METALLOSIS. UPDATE: IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DISLOCATION. UPDATE: PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2012 (RIGHT HIP).

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

  MAUDE report 8428046 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES PAIN, LIMITED MOBILITY, DIFFICULTY STANDING, SITTING, WALKING, SLEEPING, DIFFICULTY PERFORMING DAILY LIVING ACTIVITIES, ANXIETY, MENTAL ANGUISH, UNNECESSARY REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 8264579 ↗
• InjuryDec 17, 2018Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS BEFORE FIRST REVISION. DOI: (B)(6) 2003 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Pain; Test Result

  MAUDE report 8170291 ↗
• InjurySep 12, 2018Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE SURGEON DECIDED THAT THE STEM HAD SUBSIDED AND NEEDED TO BE REVISED TO A LARGER SIZE. THE STEM LOOSENING SEEMED TO BE DUE TO NOT HAVING A GOOD METAPHYSEAL FIT THE PATIENT STEM WAS REMOVED AND CANAL WAS PREPPED WITH REAMERS AND BROACHES FOR A LARGER STEM. NEW STEM AND HEAD WERE IMPLANTED. THE STEM WAS LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018. DOR: (B)(6) 2018. RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7868209 ↗
• InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THE FOLLOWING: TWO WEEKS FOLLOWING SURGERY, PATIENT'S HIP SPONTANEOUSLY DISLOCATED WHILE SHE WAS LAYING QUIETLY, 911 WAS CALLED AND PATIENT WAS TAKEN TO THE EMERGENCY ROOM. AFTER RELOCATING THE PINNACLE HIP, PATIENT WAS PLACED IN A RESTRAINING BRACE WHICH LEFT HER ESSENTIALLY BEDRIDDEN FOR THE NEXT TWO MONTHS. HOWEVER, IN THE MONTHS AFTER SURGERY, PATIENT CONTINUED HAVING INCREASING PAIN IN HER HIP. IN (B)(6) 2011 PATIENT WAS DIAGNOSED WITH "INFLAMMATORY SYNOVITIS FROM METAL" AND TESTED FOR AND DIAGNOSED WITH ELEVATED METAL LEVELS. DUE TO THE PAIN ASSOCIATED WITH HER PINNACLE HIP, PATIENT WAS NO LONGER ABLE TO STAND FOR ANY PERIOD OF TIME, WAS NO LONGER ABLE TO CARRY OUT HER DUTIES AS A REGISTERED NURSE WORKING WITH BABIES IN THE NEWBORN INTENSIVE CARE UNIT. THIS RESULTED IN THE LOSS OF THE PROFESSIONAL POSITION SHE HAD HELD FOR THE PAST 23 YEARS. PATIENT HAS SUFFERED FROM INJURIES OF A PERMANENT, LASTING AND PAINFUL NATURE. FURTHERMORE, PATIENT'S ABILITY TO PERFORM NORMAL AND ENJOY REGULAR ACTIVITIES HAS BEEN IMPAIRED. DOI: (B)(6) 2009 - NO REVISION REPORTED AT THIS TIME. (RIGHT SIDE) . UPDATE 24 APR 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECE

  Patient problems: Inflammation; Injury; Not Applicable; Pain; Test Result

  MAUDE report 7812380 ↗
• MalfunctionAug 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  COMPLAINT DESCRIPTION: DER STATES WENT TO PUT SUMMIT HI SIZE 2 STEM IMPLANT IN AND THE IMPLANT SAT MORE PROUDLY THAN BROACH FOR ABOUT 8-9MM OFF. SURGEON BROACHED AGAIN AND TRIED TO PUT THE SAME STEM IN AND IT SAT UP PROUD, NOT AS MUCH AS BEFORE BUT STILL SAT PROUD. THE TRIED A DIFFERENT SUMMIT BROACH AND IT DIDN'T IMPROVE THE SITUATION. THEN, THEY OPENED A SECOND SIZE 2 HI SUMMIT AND IT WENT DOWN TO WHERE IT SHOULD GO DOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776496 ↗
• InjuryJul 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS INFECTION. LOOSENING WAS ALSO REPORTED, BUT WAS DUE TO THIS INFECTION. UPDATE: LITIGATION PAPERS RECEIVED 1/2/14. LITIGATION ALLEGES PAIN, DISCOMFORT, IMMOBILITY, INFLAMMATION AND HIGH LEVELS OF COBALT AND CHROMIUM. THE MDR DECISION IS BEING REVERSED AND THE LINER AND HEAD ARE NOW BEING REPORTED TO ADDRESS THESE ALLEGATIONS. THE COMPLAINT HAS BEEN UPDATED ON 1/14/2014 UPDATE REC'D 5/27/2014¿ PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON 6/19/2014. ADDITIONAL INFORMATION: DOI: (B)(6) 2010 DOR: (B)(6) 2013; (LEFT HIP). COMPLAINT FILE CONTENTS HAVE BEEN ATTACHED. SR/06-09-14 12/8/14 UPDATE PATIENT HARMS AND/OR COMPLAINT CATEGORY NR. DOI: (B)(6) 2010; DOR: (B)(6) 2013; (LEFT HIP). COMPLAINT FILE CONTENTS HAVE BEEN ATTACHED. SR/06-09-14. 12/8/14 UPDATE PATIENT HARMS AND/OR COMPLAINT CATEGORY NR. UPDATE: AD (B)(6) 2018. (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO PPF AND STICKER SHEETS RECEIVED. THERE IS NO NEW ALLEGATION IN PPF. AFTER REVIEW OF MEDICAL RECORD FROM PREVIOUS ATTACHMENT, IT WAS STATED THAT PATIENT HAD A TH

  Patient problems: Abscess; Discomfort; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Pain; Test Result; Unspecified Infection

  MAUDE report 7698995 ↗
• InjuryJun 19, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT WAS REVISED TO ADDRESS SUBSIDENCE. DOI: (B)(6) 2018; DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7613289 ↗
• InjuryJun 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  LITIGATION ALLEGES PAIN AND SUFFERING, TISSUE DAMAGE, PSEUDOTUMORS AND ELEVATED METAL ION LEVELS. PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. RECEIPT OF LITIGATION RECORD. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, LITIGATION ALLEGES INJURY AND EMOTIONAL DISTRESS. DOI: (B)(6) 2006; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Distress; Injury; Not Applicable; Pain; Test Result; Tissue Damage

  MAUDE report 7591554 ↗