SUMMIT 1570-02-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295059462), received between Aug 25, 2017 and Aug 23, 2023 — classified as 45 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO A FRACTURE AROUND THE STEM. THE SURGEON DECIDED TO CONVERT TO A DM, SINCE PATIENT WAS AT RISK FOR DISLOCATION. LOOSENING OF THE STEM IS ALSO INDICATED AT BONE TO IMPLANT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 17603090 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT THAT A METAL ON METAL LINER EXCHANGE WAS COMPLETED. THE LINER WAS EXCHANGED DUE TO PATIENT EXPERIENCING PAIN AND AN INCREASED LEVEL OF COBOLT CHROME IN THE PATIENTS BLOOD WORK.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17127556 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 12 MAY 2022. AFTER REVIEW OF LITIGATION RECORDS, PLAINTIFF ALLEGES SEVERE PAIN AND DISCOMFORT, INCREASED METAL IONS, PERMANENT INJURIES, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, ECONOMIC DAMAGES. DOI: (B)(6) 2008, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Metal Related Pathology; Osteolysis; Pain; Pocket Erosion; Synovitis; Unspecified Tissue Injury

  MAUDE report 14518314 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT THA PERFORMED IN 2008 DUE TO OSTEOARTHRITIS. ASR IMPLANTS AND DEPUY SUMMIT STEM WERE USED. REVISION WAS COMPLETED SECONDARY TO PAIN AND METALOSIS. OPERATIVE NOTES STATED THAT THERE WAS A SLIGHT INCREASE IN IRON LEVELS. MRI DID NOT SHOW EVIDENCE OF PSEUDOTUMOR. SIGNIFICANT INFLAMMATION OF THE CAPSULE AND EROSION OF THE BONY INFERIOR ASPECT OF THE ACETABULUM WAS OBSERVED. PATIENT ALSO EXPERIENCED SIGNIFICANT TRUNNIONOSIS FROM THE COBALT CHROME HEAD. DOI: (B)(6) 2008, DOR: (B)(6) 2020, LEFT HIP.

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

  MAUDE report 13172668 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED. ALL IMPLANTS REMOVED. DOI: (B)(6) 2018, DOE: (B)(6) 2021, AFFECTED SIDE : RIGHT HIP.

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

  MAUDE report 12475175 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORD RECEIVED. PATIENT ALLEGES THAT THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PATIENT'S ACETABULUM, GRINDING, AND CLICKING FOR SEVERAL MONTHS, CAUSED PATIENT'S SEVERE PAIN, AND INHIBITED ABILITY TO WALK. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS METALOSIS. PATIENT HAD ELEVATED METAL ION. REVISION NOTES STATED THAT THERE IS SIGNIFICANT INFLAMMATION OF THE CAPSULE. THERE WAS SOME EROSION OF THE BONE ON THE INFERIOR ASPECT OF THE ACETABULUM. THERE WAS TRUNNIONOSIS FROM THE COBALT CHROME HEAD AGAINST THE TRUNNION AND THERE WAS SIGNIFICANT SALT FORMATION OF THE NECK. DOI:(B)(6) 2008 - DOR: (B)(6) 2020. (LEFT HIP).

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Inflammation; Pain

  MAUDE report 11872642 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND FAILED RIGHT HIP ARTHROPLASTY. OPERATIVE NOTE REPORTED OF BLACK TO GRAY APPEARANCE CONSISTENT WITH METALLOSIS ON THE INTERNAL PORTION OF THE CAPSULE. IT WAS ALSO INDICATED THAT THE ACETABULAR COMPONENT ITSELF WAS NOTICEABLY LOOSE. THE FEMORAL COMPONENT WAS WELL FIXED WITH MINIMAL METALLIC CHANGES TO THE TAPER. DOI: (B)(6) 2010 DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 11784678 ↗
• InjuryOct 19, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT FELL (B)(6) 2020 AND FRACTURE HIS RIGHT HIP. A SURGEON PERFORMED A HEMI HIP ARTHROPLASTY USING A 54 BIOPOLAR HEAD AND 5 STD SUMMIT STEM. ACCORDING TO THE SURGEON ON CALL, THE PATIENT FELL AGAIN ON (B)(6) 2020 AND CAUSED A PERIPROSTHETIC FRACTURE. THE SURGEON TOLD ME THIS PATIENT HAS DEMENTIA AND WASN'T FOLLOWING THEIR ORDERS. THE SURGEON REMOVED THE SUMMIT STEM AND BIPOLAR HEAD. THE SURGEON FIXED AND CABLED THE FRACTURE WITH A TROCH PLATE. THE SURGEON THEN PREP THE FEMUR CANAL FOR A CORAIL REVISION STEM. THE SURGEON TRIALED USING A BIPOLAR TRIAL AND SAME 28MM HEAD LENGTH. HE WAS HAPPY WITH THE STABILITY SO THE SURGEON CHOSE TO KEEP THE OLD 54 BIPOLAR HEAD W OLD 28 HEAD AND IMPLANTED IT BACK ON THE NEW CORAIL REVISION STEM. IT ALSO STATES LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

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

  MAUDE report 10698424 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIPARTHROPLASTY SECONDARY TO METAL ON METAL REACTION. IT WAS STATED THAT THE PATIENT WAS IMPLANTED WITH ASR XL COMPONENT. PATIENT ALLEGES GAIT DISTURBANCE, JOINT PAIN, JOINT WEAR, FAILURE, ELEVATED METAL IONS, AND ADVERSE SOFT TISSUE REACTION. REVISION NOTES STATED THAT THERE WAS NOTED TO BE SOME PSEUDOTUMOR EMBEDDED IN THE INTERVAL BETWEEN THE ABDUCTOR AND VASTUS LATERALIS ORIGIN AND IT WAS DEBRIDED. THE JOINT FLUID WAS ENCOUNTERED AND APPEARED NORMAL IN APPEARANCE. THERE WAS FLUID REACTION WITH A PSEUDOCAPSULE THAT EXTENDED INTO THE ANTERIOR ACETABULUM WHICH WAS DEBRIDED. SYNOVECTOMY WAS PERFORMED ABOUT THE STEM AND THE STEM WAS NOTED TO BE WELL FIXED. THE ACETABULAR COMPONENT WAS NOTED TO BE IN SLIGHT NEUTRAL VERSION, BUT WAS NOTED TO BE WELL FIXED USING CURVED OSTEOTOME. EXTENSIVE SYNOVECTOMY WAS PERFORMED TO REMOVE ALL THE SOFT TISSUE REACTION. HEAD AND CUP WERE REMOVED. DOI: UNKNOWN - DOR: (B)(6) 2018 (LEFT HIP).

  Patient problems: Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result

  MAUDE report 10191132 ↗
• InjuryFeb 5, 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, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PROSTHETIC JOINT INFECTION, POSSIBLY CHRONIC. IT WAS STATED THAT THE SPECIMEN OF LEFT HIP SYNOVIUM YIELDED OVER 100 WBCS PER HIGH-POWER FIELD CONFIRMING DIAGNOSIS OF INFECTION. PROSTALAC COMPONENTS WERE IMPLANTED. DOI: (B)(6) 2010; DOR: (B)(6) 2015; LEFT HIP.

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

  MAUDE report 9671103 ↗
• InjuryJan 7, 2020Corroded; Degraded; Corroded; Degraded

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE 08 JUN 2018 (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METAL WEAR, AND METALLOSIS. ADDED PATIENT'S AGE, REVISION SURGEON, REVISION HOSPITAL, AND LAW FIRM. UPDATED PRODUCT DETAILS OF UNKNOWN HEAD AND LINER. DOI: (B)(6) 2006; DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Anemia; Discomfort; Hypersensitivity/Allergic reaction; No Code Available; Pain; Swelling; Test Result; Thyroid Problems; Tissue Damage; Weakness

  MAUDE report 9557309 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: (04/07/2017) LEGAL DOCUMENTS RECEIVED. ALLEGES UNSPECIFIED INJURIES DUE TO THE IMPLANTATION OF PINNACLE PRODUCTS AND APPURTENANT PARTS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES BONE FRACTURE, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. THE UNKNOWN HIP IMPLANT HAS BEEN ADDED TO CAPTURED THE ALLEGATION OF A FRACTURE AS IT IS UNKNOWN WHERE THE FRACTURE WAS. IF/ WHEN MORE INFORMATION IS RECEIVED, THE PC WILL BE UPDATED AS NEEDED. DOI: (B)(6) 2010. DOR: (B)(6) 2016, (LEFT HIP, FIRST REVISION). PATIENT IS BILATERAL PLEASE SEE (B)(4) FOR THE RIGHT HIP FIRST REVISION.

  Patient problems: Foreign Body Reaction; Test Result

  MAUDE report 9401164 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS METALLOSIS. UPDATE AD 21 AUG 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO THE RECEIPT OF MEDICAL RECORDS. PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS FAILED LEFT TOTAL HIP ARTHROPLASTY SECONDARY TO METAL-METAL ARTICULATION AND METALLOSIS. THERE WAS NO MENTION OF METAL WEAR AND NO LAB RESULTS FOR ELEVATED METAL IONS. DOI (B)(6) 2009; DOR (B)(6) 2016; (LEFT HIP).

  Patient problems: Foreign Body Reaction; No Code Available; Test Result

  MAUDE report 9124058 ↗
• InjurySep 12, 2019Osseointegration Problem; Osseointegration Problem

  PPF ALLEGES CONSTRAINED LINER, ELEVATED METAL IONS AND LOOSENING OF THE STEM. STEM: DOI: (B)(6) 2007; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9011748 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN IN HER GROIN, BUTTOCKS, AND LEG, AS WELL AS NUMBNESS AND DIFFICULTY SITTING, WALKING, AND LAYING. UPON THE LEFT SIDE REVISION SURGERY FOR A LOOSE ACETABULAR COMPONENT, IT WAS DISCOVERED THAT THE PATIENT SUFFERS FROM BONE LOSS DUE TO METALLOSIS. UPDATE (B)(6) 10 JUL 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEET. PPF ALLEGES ELEVATED METAL IONS AND METAL WEAR. UPDATED PATIENT IDENTIFIER. DOI: (B)(6) 2008- DOR: (B)(6) 2010, (LEFT SIDE). PC HAS BILATERAL IN (B)(4).

  Patient problems: Foreign Body Reaction; Hypoesthesia; Loss of Range of Motion; No Code Available; Pain; Test Result

  MAUDE report 8889277 ↗
• InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORD RECEIVED. PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS AFTER FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, THERE WERE NO REVISION NOTES PROVIDED. DOI: (B)(6) 2012 - DOR: NONE REPORTED , (RIGHT HIP).

  Patient problems: Hypersensitivity/Allergic reaction; Test Result

  MAUDE report 8884051 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A RIGHT TOTAL HIP. THE SAME DAY OF SURGERY, THE PATIENT TOOK A STEP IN HER RECOVERY ROOM AND SUFFERED A PERIPROSTHETIC FRACTURE OF HER FEMUR. THE SURGEON PULLED OUT HER STEM AND REPAIRED THE FRACTURE AND IMPLANTED A NEW STEM. THE PATIENT IS STABLE. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT HIP.

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

  MAUDE report 8807147 ↗
• MalfunctionJun 25, 2019Fracture; Fracture

  PATIENT CONTACTED DEPUY STATING THAT SHE IS WORRIED THAT SHE WILL HAVE THE SAME PROBLEMS WITH HER RIGHT HIP THAT SHE HAD WITH HER LEFT HIP (REPORTED IN A SEPARATE COMPLAINT). UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF THE CUP, COMPONENT FRACTURE, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2007, DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Foreign Body Reaction

  MAUDE report 8730858 ↗
• InjuryApr 17, 2019Malposition of Device; Naturally Worn; Malposition of Device; Naturally Worn

  MEDICAL RECORDS RECEIVED. IT WAS INDICATED THAT THE PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. THE PATIENT HAD DISLOCATED THRICE PRIOR TO BEING REVISED. DURING THE SURGERY, THERE WAS A LARGE AMOUNT OF COTTAGE CHEESE-LIKE MATERIAL IN THE SUBCUTANEOUS AREA WITH A CYSTIC MEMBRANE CONSISTENT WITH A SUBCUTANEOUS BURSA WHICH APPEARED TO BE INFLAMMATORY. THERE WAS ALSO PRESENCE OF A DARK WATERY SEROSANGUINEOUS FLUID CONSISTENT WITH TRAUMA FROM THE DISLOCATION. THERE WAS A SMALL NICK IN THE STEM WHICH THE SURGEON THOUGHT WAS CAUSED BY THE STEM IMPINGING WITH THE PREVIOUSLY REVISED ASR IMPLANTS. THE STEM WAS ALSO NOTED TO BE ANTEVERTED. THE SURGEON NOTED THAT THE REASON FOR THE DISLOCATION WAS DUE TO THE ABSENCE OF POSTERIOR TISSUE. THE FEMORAL HEAD WAS STAINED WITH MULTIPLE STRIPES OF TITANIUM DEBRIS. A LARGE FIBROMA WAS DISCOVERED WHICH CONTRIBUTED TO THE POSTERIOR INSTABILITY THROUGH IMPINGEMENT OF SOFT TISSUE. DOI: (B)(6) 2018 - DOR: (B)(6) 2018, (LEFT HIP). PREVIOUS REVISION INVOLVING ASR XL IMPLANTS IS ON (B)(4).

  Patient problems: Cyst(s); Inflammation; No Code Available; Tissue Damage

  MAUDE report 8522796 ↗
• InjuryApr 17, 2019Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  LITIGATION ALLEGES LOOSENING OF THE STEM. DOI: (B)(6) 2010, DOR: (B)(6) 2014, (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8522294 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: (B)(6) 2014; (LEFT HIP).

  Patient problems: Inflammation; No Code Available; Pain; Swelling; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8518814 ↗
• InjuryApr 8, 2019Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECEIVED. LITIGATION ALLEGES FAILED HIP ASR SYSTEM. UPDATE AD 26 MAR 2019. MEDICAL RECORDS RECEIVED AND REVIEWED. INDICATING THAT THE PATIENT WAS REVISED TO ADDRESS PAIN, OSTEOLYSIS AND STRESS FRACTURE OF THE GREATER TROCHANTER.

  Patient problems: Injury; No Code Available; Osteolysis; Pain; Tissue Damage

  MAUDE report 8490876 ↗
• InjuryApr 2, 2019Biocompatibility; Biocompatibility

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES DAILY PAIN IN AND AROUND PLAINTIFF'S HIP.

  Patient problems: Discomfort; Pain; Swelling; Test Result

  MAUDE report 8473002 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE PFS REPORTED PAN, DIFFICULTY WALKING AND TROUBLE WITH NORMAL ACTIVITIES OF DAILY LIVING. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: (B)(6) 2015 (RIGHT HIP).

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result

  MAUDE report 8432488 ↗
• InjuryFeb 4, 2019Biocompatibility; Biocompatibility

  LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED PAIN, SWELLING, LACK OF MOBILITY, DAMAGE TO SURROUNDING TISSUE AND BONE CAUSED BY INFLAMMATION, METALLOSIS, PSEUDOTUMOURS, BURSITIS, AND BONE EROSION. PATIENT IS A RESIDENT OF (B)(6). UPDATE AD 4 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PPF ALLEGES METAL WEAR. METALLOSIS AND ELEVATED METAL IONS. PATIENT HARM, UNKNOWN LINER AND THE UNKNOWN HEAD WERE UPDATED AND ADDED PRODUCT CODE, LOT NUMBER, PATIENT DATE OF BIRTH, AND THE SIDE OF THE HIP. STEM WAS ADDED TO THE IMPACTED PRODUCT DUE TO THE ALLEGED ELEVATED METAL IONS FROM THE PPF. DOI: (B)(6) 2003; DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Inflammation; Limited Mobility Of The Implanted Joint; Pain; Pocket Erosion; Swelling; Test Result; Tissue Damage

  MAUDE report 8300997 ↗