SUMMIT POROCOAT 1570-11-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 186 adverse event reports that list this exact device (DI 10603295060086), received between Aug 9, 2017 and Apr 17, 2026 — classified as 184 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Degraded” (18 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 186 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMES IN TODAY WITH A PERI PROSTHETIC FRACTURE. DR REMOVED THE POLY, STEM AND HEAD SINCE THEY WERE LOOSE AND WENT BACK IN WITH A RECLAIM MONOBLOCK STEM. NO FURTHER PATIENT INFORMATION WAS AVAILABLE AT THIS TIME. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Limb Fracture

  MAUDE report 24909482 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEFT FEMUR PERI PROSTHETIC FRACTURE. HEAD AND LINER EXCHANGE. FEMUR WAS CABLED AND PLATED WITH COMPETITIVE COMPANY'S IMPLANTS. DEPUY HEAD AND LINER EXCHANGE. DOI: ON (B)(6) 2018, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 24414714 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DISLOCATED, SO DOCTOR REVISED AND USED CERCLAGE WIRES. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24084969 ↗
• InjuryAug 28, 2025Degraded; Degraded

  ON (B)(6) 2010, PATIENT UNDERWENT A RIGHT TOTAL HIP REPLACEMENT. ON (B)(6) 2023, PATIENT UNDERWENT ASPIRATION RIGHT HIP DUE TO RIGHT PAINFUL TOTAL HIP ARTHROPLASTY. ON (B)(6) 2023, THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY DUE TO ADVERSE METAL REACTION AND ELEVATED COBALT LEVELS. THE PATIENT HAD INCREASE FATIGUE AND DEPRESSION THEN DEVELOPED TREMORS AND EVENTUALLY MORE PAIN. DURING OPERATIONS, RUSTY COLORED FLUID UPON INCISION INTO THE CAPSULE ALONG WITH NECROTIC RUSTY-STAINED TISSUE ON THE INSIDE OF THE CAPSULE WERE FOUND. FURTHERMORE, A FAIR AMOUNT OF BONE LOSS WAS NOTED AND BONE WAS EXTREMELY THIN AND RIDGE COULD BE PALPATED. IT WAS ALSO OBSERVED THAT THERE WAS CORROSION OCCURRING AT THE TAPER JUNCTION IN THE FEMORAL NECK. DOI: (B)(6) 2010, DOR: (B)(6) 2023, AFFECTED SITE: RIGHT HIP.

  Patient problems: Bone Notching; Cramp(s) /Muscle Spasm(s); Depression; Fatigue; Foreign Body Reaction; Metal Related Pathology; Necrosis; Pain

  MAUDE report 22916053 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPLANTATION OF THE THA DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21872978 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALL AND HAD A FEMUR FRACTURE. STEM AND HEAD WERE REMOVED AND REPLACED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 21678047 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED, FOR PERIPROSTHETIC FRACTURE, FEMORAL/NON-DISPLACED SMALL AVULSION FX OF GREATER TROCHANTER. DEVICE RELATEDNESS: REMOTE POSSIBILITY. PROCEDURE RELATEDNESS: REMOTE POSSIBILITY. DATE OF EVENT: (B)(6) 2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INFORMATION PROVIDED. DEPUY SYNTHES PRODUCTS USED: CATALOG ID: 136505000, LOT ID#: 4476123, COMPONENT TYPE: HEAD, DESCRIPTION: ARTICUL/EZE MSPEC FEMORAL HEAD 40MM 1.5 OFFSET 12/14 TAPER. CATALOG ID: 157011135, LOT ID#: M64N57, COMPONENT TYPE: STEM, DESCRIPTION: SUMMIT STEM POROCOAT HIGH OFFSET SZ 7. CATALOG ID: 472252440, LOT ID#: 4460635, COMPONENT TYPE: LINER, DESCRIPTION: EMSYS LNR AOX +4N 52X40. CATALOG ID: 471052300, LOT ID#: 4526618, COMPONENT TYPE: SHELL, DESCRIPTION: EMSYS SHL 3HOLE 52.

  Patient problems: Ambulation or Postural Difficulties; Limb Fracture; Pain

  MAUDE report 20748234 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. IT WAS REPORTED ON SEPTEMBER 20, 2024 A CLINICAL ADVERSE EVENT WAS RECEIVED FOR RIGHT PERIPROSTHETIC FRACTURE - FEMORAL. DATE OF IMPLANT WAS (B)(6) 2019.

  Patient problems: Limb Fracture

  MAUDE report 20441338 ↗
• InjurySep 11, 2024Migration; Migration

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL RADIOGRAPHIC EVALUATION DEVICE RELATEDNESS: DEFINITELY NOT PROCEDURE RELATEDNESS: REMOTE POSSIBILITY DATE OF EVENT: (B)(6) 2024 DATE OF IMPLANT: NO INFORMATION PROVIDED TREATMENT/IMPACT: NO INFORMATION PROVIDED ADDITIONAL EVENT INFORMATION ON (B)(6) 2024, THE PATIENT HAD A RIGHT HIP REVISION TO ADDRESS RIGHT HIP PERIPROSTHETIC FEMUR FRACTURE WITH OPEN REDUCTION INTERNAL FIXATION, PERIPROSTHETIC FEMUR FRACTURE, USING. THE INDICATION INCLUDED THAT THE PATIENT HAD INCREASING PAIN AND DISCOMFORT, A MILDLY DISPLACED PROXIMAL FEMUR FRACTURE OF THE MEDICAL CORTEX WITH SUBSIDENCE OF THE STEM. DURING THE PROCEDURE THE SURGEON OBSERVED THAT THE STEM HAD SUBSIDED SIGNIFICANTLY.

  Patient problems: Discomfort; Limb Fracture; Pain

  MAUDE report 20188797 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A PERIOD OF PROSTHETIC FRACTURE WHILE BENDING OVER IN A FISHING BOAT. SURGEON REMOVED THE SUMMIT PORO STEM AND IMPLANTED A RECLAIM MONO BLOCK. SURGEON SWAPPED THE EMPHASYS DUAL MOBILITY LINER AND METAL HEAD AS WELL AS. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 20183384 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER MEDICAL RECORDS REVIEW PATIENT WAS REVISED DUE TO RECENT EXPERIENCE IN INCREASED LEFT HIP PAIN AND ELEVATED COBALT-CHROMIUM LEVELS WITH POSITIVE FLUID COLLECTION AS SEEN ON MARS MRI. OPERATIVE NOTE REPORTED. THE HIP WAS DISLOCATED AND THE UNIPOLAR LARGE FEMORAL HEAD WAS REMOVED IN ITS ENTIRETY, DEMONSTRATING A SIGNIFICANT WEAR ALONG THE TRUNNION WITH A BLACK COBALT CHROMIUM MATERIAL. DOI: (B)(6) 2007; DOR: (B)(6) 2024; LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 19920339 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, HIP PAIN AND LIMITED ADL. OPERATIVE NOTE REPORTED. THERE WAS A SMALL AMOUNT OF MILDLY CLOUDY FLUID NOTED ON ENTRY TO THE HIP JOINT, SCAR TISSUE IN THE HIP JOINT WITH MILD EVIDENCE TO GRAY STAINING FROM METAL DEBRIS. THERE WAS A SMALL AMOUNT OF TISSUE AROUND THE LINER WITHIN THE CUP. HEAD AND LINER REVISION. CLINICAL VISIT ON (B)(6) 2023 HAD IMPRESSION OF OSTEOLYSIS, BURSITIS OR TENDINITIS DOI: (B)(6) 2008. DOR:(B)(6) 2023. RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Inflammation; Loss of Range of Motion; Muscle/Tendon Damage; Osteolysis; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19919246 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS HIP REPLACED AT A DIFFERENT HOSPITAL BY SURGEON ON (B)(6) 2023 AND DID WELL UNTIL RECENTLY WHEN HE BEGAN TO EXPERIENCE PAIN AND DISCOMFORT. THE SURGEON ASPIRATED HIS HIP AND CONFIRMED THAT HE HAD AN INFECTION AND MADE THE DECISION TO RESECT THE IMPLANTS AND IMPLANT A PROSTALAC STEM. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 19352079 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE - FEMORAL. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6).2023 DATE OF EVENT: (B)(6).2024 (LEFT HIP) TREATMENT: NONE.

  Patient problems: Limb Fracture

  MAUDE report 18746551 ↗
• InjuryMay 5, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECORD RECEIVED. ON OR ABOUT (B)(6) 2008, PATIENT WAS IMPLANTED WITH ASR HIP IN THE LEFT HIP. ON OR ABOUT (B)(6) 2022, PATIENT WAS REVISED. LITIGATION ALLEGED PAIN, DISCOMFORT, ELEVATED METAL IN BLOODS INCLUDING COBALT AND CHROMIUM. DOI: (B)(6) 2008; DOR: (B)(6) 2022; LEFT HIP.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Anxiety; Discomfort; Foreign Body Reaction; Metal Related Pathology; Necrosis; Osteolysis; Pain; Scar Tissue

  MAUDE report 16875996 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HIS RIGHT HIP REPLACED ON (B)(6) 2023 AT (B)(6) WHERE HE RECEIVED A SUMMIT PINNACLE CONSTRUCT. HE BEGAN TO EXPERIENCE SOME DISCOMFORT AND DRAINAGE COMING FROM HIS WOUND A FEW WEEKS AFTER SURGERY. THE PATIENT WAS BROUGHT IN FOR AN I&D AND IMMEDIATE EXCHANGE OF ALL COMPONENTS. THE SUMMIT STEM, HIP BALL, PINNACLE CUP, AND PINNACLE LINER WERE ALL EXPLANTED. THE WOUND WAS THOROUGHLY DEBRIDED AND NEW COMPONENTS WERE IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Fluid Discharge

  MAUDE report 16511991 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM, INFECTION, AND ELEVATED METAL IONS. STEM WAS ALREADY REPORTED IN THE FIRST REVISION. DOI: ON (B)(6) 2012 - DOR: ON (B)(6) 2012 (RIGHT HIP). DOI: ON (B)(6) 2004 (CUP AND SCREW). THIS PC IS FOR THE SECOND REVISION OF THE RIGHT HIP. SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Adult Respiratory Distress Syndrome; Fever; Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Loss of Range of Motion; Pain; Pulmonary Embolism; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 16255408 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO FRACTURE OF FEMUR. PATIENT FELL CAUSING THE FRACTURE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: YEAR 2016. DOR: (B)(6) 2014. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 15848007 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION (MAPPED TO MW) LITIGATION PAPERS ALLEGE PAIN, STIFFNESS, BODILY INJURIES, AND DISFIGUREMENT. UPDATE REC'D 5/27/15- LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE OUTCOME OF THE INVESTIGATION. UPDATE 9-2-15 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PART/LOT IS BEING UPDATED. THE COMPLAINT WAS UPDATED ON:10/1/2015.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15369278 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE PAIN, STIFFNESS, BODILY INJURIES, AND DISFIGUREMENT. UPDATE 9/2/2015 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, PART/LOT IS BEING UPDATED. A STICKER SHEET FOR A REVISION OPERATION HAS BEEN PROVIDED, BUT NO OPERATIVE NOTE. THE COMPLAINT WAS UPDATED ON: 10/1/2015.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Distress; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Pain

  MAUDE report 15348926 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PERIPROSTHETIC FRACTURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2022. (RIGHT HIP). TREATMENT: REVISION; HEAD WAS REMOVED.

  Patient problems: Fall; Limb Fracture

  MAUDE report 15211527 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FRACTURE (FEMORAL). EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; (RIGHT HIP). TREATMENT: REVISION (UNKNOWN COMPONENTS).

  Patient problems: Cardiac Arrest; Fall; Limb Fracture

  MAUDE report 15115750 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WAS DUE TO REMOVAL OF FLUID, REMOVAL OF YELLOWISH FIBRINOUS MATERIAL, REMOVAL OF A LARGE CYSTIC LESION AT THE PROXIMAL FEMORAL ANTERIOR NECK REGION, SOFT TISSUE DEBRIDEMENT, REMOVAL AND BONE GRAFTING DUE TO TOXIC HEAVY METAL AND METAL ION COBALT AND CHROMIUM POISONING, PAIN, TISSUE AND BONE DESTRUCTION, METAL WEAR, EMOTIONAL TRAUMA AND DISTRESS, ELEVATED COBALT AND CHROMIUM LEVELS. DOI: (B)(6) 2007. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Adhesion(s); Cyst(s); Distress; Fall; Foreign Body Reaction; Inflammation; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15105045 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SAID THAT THEY WERE EXPERIENCING HIP PAIN AFTER THEIR SURGERY. THE SURGEON HAD TRIED TO CORRECT THEIR LEG LENGTH SINCE THEY WERE SHORT BEFORE SURGERY. HE BELIEVES RESTORING THE LEG LENGTH WAS CAUSING PAIN THROUGH SOFT TISSUE STRETCHING. HE DECIDED TO REMOVE IMPLANTS AND MAKE A SHORTER NECK CUT AND SINK A SMALLER STEM. TRIALING WITH THE SMALLER STEM THE HIP WAS UNSTABLE WITH THE NEUTRAL CERAMIC LINER. HE REMOVED THE CERAMIC LINER AND CUP AND IMPLANTED A NEW CUP AND +4 10 DEGREE POLY LINER. HE TRIALED AGAIN FOR STABILITY. HE IMPLANTED NEW STEM AND TRIALED AGAIN FOR THE APPROPRIATE SIZE HEAD FOR STABILITY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Physical Asymmetry; Unspecified Tissue Injury

  MAUDE report 15094416 ↗
• InjuryJul 19, 2022Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AFTER THEIR SURGERY THE PREVIOUS DAY. HE BELIEVED THE PATIENT WAS VERY SHORT BEFORE THEIR PRIMARY SURGERY AND MAY HAVE BEEN LENGTHEN TOO MUCH EVEN THOUGH HE HAD USED THE SHORTEST HEAD. HE TOOK BACK TO SURGERY AND REMOVED THE PATIENT STEM. HE MADE A NEW NECK CUT AND WAS ABLE TO IMPLANT THE PATIENT STEM BACK IN AFTER PREPPING THE FEMUR. HE IMPLANTED THE APPROPRIATE SIZE HEAD FOR STABILITY. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Pain; Physical Asymmetry

  MAUDE report 15051556 ↗