SUMMIT POROCOAT 1570-01-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295059332), received between Nov 24, 2014 and Apr 25, 2025 — classified as 33 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 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 A PERIPROSTHETIC FRACTURE OF THE RIGHT FEMUR. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 21908389 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT AFTER REVIEW, THE PATIENT WAS REVISED DUE TO FAILED RIGHT TOTAL HIP ARTHROPLASTY W/ ASR RECALL. PATIENT WAS EXPERIENCING PAIN AND FURTHER EXAM FOUND A PSEUDOTUMOR. DURING THE PROCEDURE THERE WAS A MASSIVE AMOUNT OF OSTEOLYTIC TYPE OF DEBRIS IN THE ACETABULUM, LYSIS FOUND BEHIND THE ACETABULUM.

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

  MAUDE report 21183556 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLAIM LETTER FROM KENNEDYS RECEIVED. REASON FOR REVISION WAS UNKNOWN. DOI: (B)(6) 2006 - DOR: (B)(6, 2015. (RIGHT HIP).

  Patient problems: Foreign Body Reaction

  MAUDE report 16131220 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORDS RECEIVED. REPORT OF AN ASR REVISION WITH UNKNOWN REASON. DOI: SEP 8, 2008, RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 14731233 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALE REP INFORM THAT PATIENT HAD IMPLANT SINCE 2019 AND RIGHT NOW THIS PATIENT FACES BROKEN JOINT SITUATION, SO HCP ASKED ABOUT THE QUALITY OF THESE ITEMS. DOI: 2019, DOR: UNKNOWN, UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 14102552 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR AN I&D, POSSIBLY AN EXCHANGE OF IMPLANTS. THE PATIENT'S INCISION APPEARED TO BE RED AND INFLAMED. WHEN GETTING INTO THE JOINT SPACE THE SURGEON FELT THE PATIENT WOULD BENEFIT FROM A FULL EXCHANGE OF IMPLANTS. WITH THE HIP ONLY BEING DONE ROUGHLY A MONTH AGO, HE FELT HE COULD EXCHANGE ALL THE IMPLANTS, PERFORM A THOROUGH WASHOUT, AND THEN RE-IMPLANT PRIMARY COMPONENTS. AFTER WASHING THE HIP, NEW IMPLANTS WERE PREPARED AND INSERTED. THE HIP WAS REDUCED AND FOUND TO BE STABLE. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inflammation

  MAUDE report 12827660 ↗
• InjuryApr 8, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS ATTEMPTING TO BEND FORWARD WHILE AT WORK AND NOTICE A POP IN HER HIP AND HAS HAD PAIN EVER SINCE. SHE WAS TESTED FOR METAL AND IRON LEVELS AT SOME POINT IN TIME AND THESE WERE NEGATIVE. IT WAS STATED THAT THEY OBTAINED X-RAYS AND FOUND THAT THE ACETABULAR COMPONENT HAD SPUN OUT AND THAT THIS IS A DEPUY ASR ACETABULAR COMPONENT. PATIENT WAS THEN REVISED FOR FAILED RIGHT HIP REPLACEMENT, ACETABULAR COMPONENT LOOSENING, ADVERSE METAL-ON-METAL REACTION. OPERATIVE NOTES REPORTED THAT THERE WAS DEBRIS AT THE TRUNNION HEAD INTERFACE CONSISTENT WITH METAL ON METAL REACTION. THE LOOSED CUP WAS REMOVED WITH NO BONE LOSS. DOI: (B)(6) 2007, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 11634341 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. THE AFFECTED SIDE OF THE PATIENT IS THE LEFT HIP.

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

  MAUDE report 11633331 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2007, THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS PSORIATIC ARTHRITIS. DEPUY ASR COMPONENTS WERE UTILIZED ALONG WITH DEPUY SUMMIT STEM. DURING THE PROCEDURE THE SURGEON OBSERVED SIGNIFICANT SYNOVITIS. ON (B)(6) 2019, THE PATIENT HAD A REVISION OF THE LEFT TOTAL HIP TO ADDRESS FAILED LEFT TOTAL HIP, ADVERSE REACTION/METAL-ON-METAL, SEVERE OSTEOLYSIS. INDICATIONS FOR SURGERY INCLUDED ELEVATED METAL ION LEVELS. DURING THE SURGERY, THE SURGEON OBSERVED TRUNNIONOSIS AND GRANULOMATOUS DEBRIS, AND OSTEOLYSIS. DEPUY COMPONENTS WERE USED DURING THIS PROCEDURE. DOI: (B)(6) 2007, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis

  MAUDE report 11596569 ↗
• MalfunctionNov 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THIS PATIENT HAD HER HIP REPLACED ON (B)(6) 2020. THE REASON FOR THE DER IS TO QUESTION IF THE IMPLANT IS WITH IN SPECIFICATIONS. THE SURGEON BROACHED UP TO A SZ 2 AND TRIALED A STANDARD OFFSET. THE TRIAL REDUCTION FELT GOOD TO THE SURGEON, SO A SZ 2 STD SUMMIT IMPLANT WAS OPENED AND DISPENSED TO THE STERILE FIELD. WHEN THE STEM WAS IMPLANTED THE SURGEON SAID THE IMPLANT WAS SITTING LOWER THAN THE BROACH AND THE SURGEON FELT IT WAS UNACCEPTABLE. THE IMPLANT WAS REMOVED, A SZ 2 BROACH WAS PUT BACK IN THE CANAL AND DID NOT SIT AS LOW AS THE IMPLANT. A SIZE 3 BROACH WAS INSERTED INTO THE FEMUR AND PROVIDED A BETTER FIT, SO A SIZE 3 STANDARD SUMMIT STEM WAS IMPLANTED. NO ADVERSE EVENTS OCCURRED , THE CASE PROCEEDED AND FINISHED AS NORMAL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10854082 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. SURGEON CHOSE TO REMOVE MOM LINER AND REPLACE WITH POLYETHYLENE LINER AND NEW HEAD. REVISION NOTES INDICATED THAT THE STEM WAS FOUND TO BE IN GOOD CONDITION WITHOUT EVIDENCE OF METALLIC CORROSION. SURGEON WAS GOING TO TRY TO UTILIZE A CERAMIC +9 HEAD ON A POLY, BUT AFTER INSPECTING THE HEAD, THERE WERE A COUPLE OF SURFACE ABRASION. DUE TO THE IRREGULARITIES OF HAVING ISSUES WITH PREMATURE WEAR, THE CERAMIC HEAD WAS REMOVED AND REPLACED WITH A COBALT CHROME HEAD. DOI: (B)(6) 2007, DOR: (B)(6) 2018, LEFT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Inflammation; Injury; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 10453826 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED METAL LINER AND HEAD BALL IN RIGHT HIP DUE TO ELEVATED ION LEVELS. THIS PATIENT HAS BILATERAL METAL ON METAL HIPS. THE LEFT HIP WAS IMPLANTED ON (B)(6) 2005 AND REVISED TO POLY LINER AND TS CERAMIC HEAD ON (B)(6) 2019. THE PATIENT IS MINIMALLY SYMPTOMATIC AND FULL WEIGHT BEARING. PATIENT HAS SUMMIT HIP STEM AND PINNACLE 54MM SECTOR CUP WHICH REMAINED IN PATIENT. HIP STEM SIZE UNKNOWN. LOT NUMBERS ON IMPLANTS REMAINING IN PATIENT UNKNOWN. REGARDING THE TWO SCREWS REMOVED FROM THE CUP, I ESTIMATED THEIR LENGTH, 25MM AND 35MM BECAUSE THE IMPLANT DATA WAS NOT AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: No Code Available; Test Result

  MAUDE report 9924612 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND PERIPROSTHETIC INFECTION. ASPIRATION WAS NEGATIVE FOR BACTERIA BUT ALSO HAD 111 WHITE BLOOD CELLS. INTRAOPERATIVELY, THERE WAS GROSS PUS, BONE LOSS, A DEFICIENCY OF THE POSTERIOR COLUMN RELATED TO THE INFECTION AND FRACTURE CRACKS IN THE PROXIMAL FEMUR. IMPLANTS WERE REMOVED AND A NON-ARTICULATING SPACER CONSTRUCT OF UNKNOWN MANUFACTURER WAS PLACED. REVISION NOTES ON THE SECOND REVISION FOR REMOVAL OF SAID SPACER ON (B)(6) 2018 INDICATE PRESENCE OF A DARK MURKY FLUID CONSISTENT WITH METALLOSIS AS WELL AS CHALKY, METALLOSIS TYPE DEBRIS. DOI: (B)(6) 2006, DOR: (B)(6) 2018 (RIGHT HIP).

  Patient problems: Abscess; Bone Fracture(s); Foreign Body Reaction; Injury; No Code Available; Pain; Unspecified Infection

  MAUDE report 9852875 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL IONS. OPERATIVE NOTE REPORTED EFFLUX OF GRAYISH THIN FLUID, SOFT TISSUE METALLOSIS, 1 CM AREA OF SPOT WELD NOTED WITHOUT ANY INGROWTH AND LIMB ASYMMETRY. DOI: (B)(6) 2009; DOR: (B)(6) 2011; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Depression; Discomfort; Foreign Body Reaction; Metal Related Pathology; No Code Available; Pain; Physical Asymmetry; Test Result

  MAUDE report 9588375 ↗
• InjuryNov 18, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AFTER A REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS THE LEFT PROXIMAL FRACTURE ON THE FEMUR, OSTEOLYSIS, METAL ION TOXICITY, PSEUDOTUMOR, AND MINIMAL TAPER WEAR ON THE FEMORAL STEM. REVISION NOTE INDICATED THAT THERE WAS A LARGE AMOUNT OF RESOLVING HEMARTHROSIS FLUID THAT WAS FOUND AFTER T-CAPSULOTOMY WAS PERFORMED. THE HEAD HAS MINIMAL TAPER WEAR AND SMALL LOCALIZED OSTEOLYTIC ON THE CUP.

  Patient problems: Bone Fracture(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Test Result

  MAUDE report 9336858 ↗
• InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES STROKE/HEART ATTACK, BONE FRACTURE AND INFECTION REQUIRING IV ANTIBIOTICS. AT THIS TIME IT¿S UNKNOWN WHERE THE FRACTURE OCCURRED. IF/WHEN MORE INFORMATION IS RECEIVED, THE PC WILL BE UPDATED AS NEEDED. PPF ALSO INDICATES THAT THE PATIENT IS DECEASED. DATE AND REASON OF DEATH WERE NOT PROVIDED. DOI: (B)(6) 2008. DOR: (B)(6) 2008, (RIGHT HIP). SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Cardiac Arrest; Infarction, Cerebral; No Code Available; Unspecified Infection

  MAUDE report 8837712 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DETAILS W.R.T ASR HIP IMPLANT: FIRST LEFT LEG TOTAL HIP REPLACEMENT WAS DONE ON (B)(6) 2006 AT (B)(6) AND IMPLANT USED WAS OF DEPUY REF: (B)(4), LOT: 2155140. FIRST REVISION TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2014 AT (B)(6) AND IMPLANT USED WAS OF DEPUY AND LEFT LEG SHORTENED BY 5CM. DUE TO DISLOCATION OF IMPLANT SECOND REVERSE THR DONE ON (B)(6) 2014 AT (B)(6). AS SEVERE INFECTION AND WATERY DISCHARGE FROM OPERATED AREA AGAIN SHE UNDERWENT REMOVAL OF THR IMPLANT, DEBRIDEMENT AND ANTIBIOTIC SPACER INSERTION ON (B)(6) 2015 AT (B)(6). AGAIN INFECTION AND WATERY DISCHARGE FROM OPERATED AREA SHE WAS ADMITTED AND SURGERY DONE ON (B)(6) 2016 REVISION LEFT THR FOR INFECTION AT (B)(6). DUE TO CONTINUOUS PRESSURE ON RIGHT LEG HER KNEE OF RIGHT LEG PAIN STARTED AND KNEE REPLACEMENT HAD TO BE DONE ON (B)(6) 2018. AS OF NOW SHE IS BEDRIDDEN MENTALLY DISTURBED AND DEPENDENT PHYSICALLY AND MENTALLY ON ALL FAMILY MEMBERS FOR ALL DAY TO DAY WORK.

  Patient problems: Injury; No Code Available; Tissue Damage

  MAUDE report 8816241 ↗
• InjuryJun 12, 2019Adverse 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 PAIN. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 8693337 ↗
• InjuryMay 15, 2019Inadequacy of Device Shape and/or Size; Use of Device Problem; Inadequacy of Device Shape and/or Size; Use of Device Problem

  IT WAS REPORTED THAT THE STEM WAS UNDERSIZED AND EXTREMELY VALGUS. THE DISTAL TIP WAS CAUSING PAIN IN THE PATIENTS FEMUR. DOI: (B)(6) 2007. DOR: APR 23, 2019. LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8611997 ↗
• InjuryApr 24, 2019Corroded; Corroded

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ADVERSE LOCAL TISSUE REACTION TO MOM DOI: (B)(6) 2003. DOR: (B)(6) 2019. (RIGHT HIP). CORROSION FOUND ON SUMMIT STEM.

  Patient problems: Loss of Range of Motion; No Code Available; Osteolysis; Pain; Tissue Damage

  MAUDE report 8545736 ↗
• InjuryMar 7, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2007. DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Cyst(s); Discomfort; Inflammation; Pain; Test Result; Tissue Damage

  MAUDE report 8398794 ↗
• InjuryDec 17, 2018Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8170395 ↗
• InjuryDec 14, 2018Biocompatibility; Biocompatibility

  PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Pain; Test Result; Tissue Damage

  MAUDE report 8164152 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. UPDATE 1/28/15 - DISC 209 PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PATIENT SUFFERS FROM PAIN. PFS IDENTIFIED PATIENT DOB, HEIGHT AND WEIGHT. THE HEAD IS NOW BEING REPORTED AND A LINER IS BEING ADDED. DOI (B)(6) 2012 - DOR (B)(6) 2013 (LEFT HIP). UPDATE AD 1 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. ADDED STEM DUE TO THIS ALLEGATION. FACILITY NAME, ASSOCIATED CONTACT, HEAD AND LINER EXPIRATION DATE WERE ALSO ADDED. DOI: (B)(6) 2012 - DOR: (B)(6) 2013 (LEFT HIP). PATIENT IS BILATERAL. PLEASE SEE (B)(4) FOR RIGHT HIP.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8077232 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND INFECTION. UPDATE AD 02 MAY 2018: WPC (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2003 - DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: No Code Available; Osteolysis; Test Result; Unspecified Infection

  MAUDE report 8045762 ↗