SUMMIT POROCOAT 1570-11-165Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295060109), received between Oct 24, 2017 and Jan 3, 2023 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BLEED WITH LARGE HEMATOMA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT HIP). TREATMENT: NONE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 16086842 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORDS RECEIVED. AFTER REVIEW OF RECORDS, LITIGATION ALLEGES THAT PATIENT CONTINUES TO SUFFER ECONOMIC, DAMAGES, SEVERE AND POSSIBLY PERMANENT INJURIES, PAIN, SUFFERING AND EMOTIONAL DISTRESS. DOI: (B)(6) 2007 (CUP AND STEM), DOI: (B)(6) 2020 (HEAD AND LINER); DOR: NONE REPORT, LEFT HIP. THIS COMPLAINT IS LINKED TO: (B)(4) - RIGHT HIP 1ST REVISION, (B)(4) - LEFT HIP 1ST REVISION, (B)(4) - ALLEGATION AFTER 1ST REVISION OF RIGHT HIP.

  Patient problems: Distress; Pain

  MAUDE report 13025231 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORDS RECEIVED. AFTER REVIEW OF RECORDS, LEGITIMATION ALLEGES THAT PATIENT CONTINUES TO SUFFER ECONOMIC, DAMAGES, SEVERE AND POSSIBLY PERMANENT INJURIES, PAIN, SUFFERING AND EMOTIONAL DISTRESS. DOI: (B)(6) 2007 (CUP AND STEM), DOI: (B)(6) 2019 (HEAD AND LINER), DOR: NONE REPORTED, RIGHT HIP. THIS COMPLAINT IS LINKED TO: (B)(4) - RIGHT HIP 1ST REVISION, (B)(4) - LEFT HIP 1ST REVISION, (B)(4) - ALLEGATION AFTER 1ST REVISION OF LEFT HIP.

  Patient problems: Distress; Pain

  MAUDE report 13018395 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND SUFFERED A PERIPROSTHETIC FRACTURE OF HIS FEMUR. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11201967 ↗
• InjuryDec 14, 2020Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT HAD A METAL ON METAL CONSTRUCT. REVISED DUE TO CORROSION ON THE HEAD NECK TAPER JOINT. CONVERTED TO A POLY ON CERAMIC CONSTRUCT. LAB RESULTS PROVIDED WERE BELOW 7 PPB. DOI: (B)(6)2007; DOR: (B)(6) 2020; LEFT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Insufficient Information; Pain

  MAUDE report 11003739 ↗
• InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER A REVIEW OF THE MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT METAL-ON-METAL TOTAL HIP ARTHROPLASTY WITH ELEVATED METAL IONS. PATIENT ALLEGES PAIN WITH RANGE OF MOTION AND IN THE KNEE, SEVERE SUDDEN PAIN THAT MAKES DIFFICULT TO WALK, AND ELEVATED METAL IONS. OPERATIVE NOTES INDICATED THAT UPON OPENING UP THE FASCIA, BLACK STAINED TISSUE WAS SEEN TRANSLUCENTLY THROUGH THIN TISSUE. BULBOUS CYSTIC TISSUE WAS NOTED WHEN FLAPS WERE CREATED. 7 ML OF CLEAR FLUID WAS REMOVED FROM THE JOINT. THE ENTIRE CYSTIC STRUCTURE WAS TAKEN DOWN OFF THE BONE WITH BLEEDING POINTS WERE COAGULATED ON THE INSIDE SHOWED BOTH WHITISH DEVITALIZED TISSUE AND SOME MILDLY BLACKISH STAINED GRAY STAINED TISSUE. THE CAPSULE APPEARED FIBROTIC. A RONGEUR WAS USED TO REMOVE OTHER SMALL AREAS OF METAL STAINED TISSUE ABOUT THE POSTERIOR TISSUES. ANY METAL STAINED TISSUE WAS DEBRIDED. THE FIBROTIC ANTERIOR TISSUE WAS EVALUATED. IT WAS FELT THAT SOME OF THIS REPRESENTED CAPSULAR TISSUE. THIS TISSUE WAS THEN TENSED AND ATTEMPT MADE TO REMOVE THE UNDERLYING METAL STAINED DEBRIS ABOUT THE ANTERIOR CAPSULE. THE MODULAR HEAD WAS NOW DISIMPACTED FROM THE TRUNNION WHICH SHOWED MINIMAL METAL STAINING. THE

  Patient problems: Adhesion(s); Cyst(s); Edema; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 9929192 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUMMIT STEM AND HEAD REVISED FOR PERIPROSTHETIC FRACTURE 8 WEEKS POST OP. DOI: (B)(6) 2020. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 9888516 ↗
• InjuryJan 3, 2020Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED THAT THE PATIENT HAS ELEVATED METAL ION LEVELS PER THE DOCTOR THAT HAVE CONTINUED TO ELEVATE, AND ALSO HAD GROIN PAIN. THERE WAS CORROSION AT THE HEAD NECK JOINT. THERE WAS ALSO SOME FIBROUS TISSUE INSIDE THE CUP AFTER THE LINER WAS REMOVED. PATIENT WAS VERY DIFFICULT TO DISLOCATE. LINER WAS REMOVED AND HEAD WAS REMOVED. POLY LINER WAS IMPLANTED WITH A NEW TS CERAMIC HEAD. FIBROUS: (B)(6) 2007; DOR: (B)(6) 2019, (RIGHT HIP).

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available; Pain; Test Result; Unspecified Tissue Injury

  MAUDE report 9546740 ↗
• MalfunctionJun 28, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AN UNKNOWN WHITE RESIDUE WAS LEFT ON THE INNER PACKAGING AFTER THE TYVEK MATERIAL WAS REMOVED. IT WAS HYPOTHESIZED THAT THE WHITE RESIDE WAS EXCESS GLUE THAT SIMPLY PULLED SOME OF THE TYVEK MATERIAL OFF. EITHER WAY, THERE WERE CONCERNS ABOUT THE "UNKNOWN AND A REPLACEMENT STEM WAS REQUESTED. THANK YOU. 2 MINUTES SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2019 LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 8745586 ↗
• InjuryApr 25, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT FRACTURED HIS FEMORAL IMPLANT DURING FALL. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 8550121 ↗
• InjuryApr 16, 2019Loss of Power; Loss of Osseointegration; Loss of Power; Loss of Osseointegration

  PPF ALLEGES ABDUCTOR MUSCLE REPAIR, METAL WEAR, METALLOSIS AND LOOSENING OF THE STEM.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Inadequate Osseointegration; No Code Available; Pain; Tissue Damage

  MAUDE report 8518827 ↗
• InjuryFeb 20, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISLOCATION AND LOOSENING OF STEM. DOI: (B)(6) 2015 DOR: (B)(6) 2017 RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8353472 ↗
• InjuryJan 29, 2019Corroded; Degraded; Material Separation; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Corroded; Degraded; Material Separation; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND CLUNKING IN THE HIP. IT WAS DETERMINED THAT THE PATIENT NEEDED AN ACETABULAR REVISION TO REMOVE ASR SHELL.

  Patient problems: Host-Tissue Reaction; No Code Available; Not Applicable; Pain

  MAUDE report 8284644 ↗
• InjuryNov 28, 2018Biocompatibility; Biocompatibility

  LITIGATION PAPERS ALLEGE THAT AFTER SURGERY, PATIENT BEGAN EXPERIENCING PAIN THAT CONTINUES TO DATE. IT IS ALSO ALLEGED THAT 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, CONSCIOUS PAIN AND SUFFERING AND LOSS OF EARNINGS. PPF ALLEGES METAL WEAR AND METALLOSIS. DOI: (B)(6) 2004 - DOR: (B)(6) 2018 (LEFT HIP).

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; Pain; Test Result; Tissue Damage

  MAUDE report 8109857 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT EXPERIENCED PAIN AND DISCOMFORT AND EXHIBITED SYMPTOMS OF A LOOSE IMPLANT. DOI: (B)(6) 2009 - DOR: (B)(6) 2010 (UNKNOWN HIP). UPDATE AD 25 APRIL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. PPF ALLEGES INFECTION. DOR WAS UPDATED TO (B)(6) 2010 DUE TO THE NEW INFORMATION RECEIVED FROM PPF AND MEDICAL RECORDS. STEM CUP AND SCREW WAS ADDED TO IPS DUE TO ALLEGED INFECTION. DOI: (B)(6) 2009- DOR: (B)(6) 2010 (RIGHT HIP) FIRST REVISION (B)(4) (SECOND REVISION).

  Patient problems: Discomfort; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 7771936 ↗
• InjuryMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT ¿. LITIGATION ALLEGES THAT THE PATIENT SUFFERED INJURY AND PAIN. UPDATE 12/19/2013 - SALES REP REPORTED REVISION SURGERY. PATIENT'S FEMORAL HEAD WAS REVISED TO ADDRESS OSTEOLYSIS. THE CUP REMAINED IN SITU. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE REC'D 09/26/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES DISCOMFORT. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014

  Patient problems: Edema; Injury; Necrosis; Not Applicable; Osteolysis; Pain; Tissue Damage

  MAUDE report 7479651 ↗
• InjuryOct 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: SEP 25, 2017: PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES INCREASED PAIN, LIMITED MOBILITY AND ELEVATED METAL IONS. THERE IS NO REVISION NOTE PROVIDED.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Test Result

  MAUDE report 6973856 ↗