SUMMIT 1570-02-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295059448), received between Jul 25, 2018 and Dec 7, 2023 — classified as 21 injuries.

The most frequently reported specific device problem is “Degraded” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH TEMPORARY ANTIBIOTIC SPACER ACTIVITY LEVEL - YES. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18283965 ↗
• InjuryApr 5, 2021Degraded; Degraded

  PRIOR TO REVISION PATIENT ALLEGES STIFFNESS, INJURY, INSTABILITY, WEAKNESS AND METALLOSIS. DURING REVISION DOCTOR FOUND OUT INFLAMED HYPERTROPHIC SYNOVIUM AND ANTERIOR CAPSULE WAS THICKENED. DOI: (B)(6) 2008 DOR: (B)(6) 2020 LEFT HIP.

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

  MAUDE report 11613153 ↗
• InjuryMar 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION OF HER LEFT HIP YEARS AFTER RECEIVING A TOTAL HIP ARTHROPLASTY. SURGEON REMOVED ALL IMPLANTS, CUP, LINER, STEM, HEAD AND REPLACED WITH PROSTALAC IMPLANTS. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT HIP.

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

  MAUDE report 11536846 ↗
• InjuryMar 18, 2021Degraded; Degraded

  PINNACLE LITIGATION RECORDS RECEIVED. PRIOR TO REVISION PATIENT ALLEGES PAIN, STIFFNESS, INJURY, INSTABILITY, WEAKNESS, METALLOSIS AND ELEVATED COBALT AND CHROMIUM LEVEL. DURING REVISION DOCTOR FOUND OUT CORROSION AT THE TRUNNION AND HEAD BORE, PSEUDOTUMOR, INFLAMED HYPERTROPHIC SYNOVIUM AND ANTERIOR CAPSULE WAS THICKENED WITH AN ARMD REACTION AND THIS WAS DEBRIDED. DOI: (B)(6) 2008; DOR: (B)(6) 2020 LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Muscular Rigidity; Pain; Synovitis

  MAUDE report 11517587 ↗
• InjuryMar 20, 2020Corroded; Degraded; Corroded; Degraded

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. THE 36+5 METAL HEAD WAS REMOVED AND THE 36X50 METAL ON METAL LINER WAS REMOVED WITHOUT INCIDENT. THE CUP AND STEM WHERE WELL FIXED AND THE WOUND WAS WASHED OUT. A 32X50 NEUTRAL ALTRX POLY LINER WAS INSERTED AND 32+9 DELTA TS CERAMIC HEAD WAS IMPLANTED. DOI: UNK. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Dizziness; Itching Sensation; No Code Available; Pain; Test Result; Tinnitus

  MAUDE report 9862266 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. THERE WERE NO ALLEGATION REPORTED IN UNF. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS RIGHT PAINFUL TOTAL HIP ARTHROPLASTY, ABDUCTOR INSERTION AVULSION AND HIP FAILED METAL ON METAL BEARING. REVISION NOTE REPORTED PAIN, ELEVATED METAL IONS, FAILURE OF HER ABDUCTOR REPAIR, TRUNIONOSIS AND THE UNDERLYING TROCHANTER WAS IDENTIFIED THAT THERE WAS A FAILURE OF THE PREVIOUS BONE FLECK, AND IT WAS ALSO MENTION THAT THERE WERE NO EVIDENCE OF METALLOSIS OR PSEUDOTUMOR. LAB RESULTS FOR METAL IONS WERE BELOW 7. DOI: (B)(6) 2010; DOR: (B)(6) 2018 (RIGHT HIP) FIRST REVISION.

  Patient problems: Bone Fracture(s); Foreign Body Reaction; No Code Available; Pain; Tissue Damage

  MAUDE report 9633713 ↗
• InjuryDec 5, 2019Corroded; Degraded; Corroded; Degraded

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS FAILED DEPUY ASR RECALLED HIP WITH LOOSE ACETABULAR COMPONENT. THERE WAS EVIDENCE OF BLACK CORROSION ON THE TAPER. THE STEM WAS NOTED TO BE WELL-FIXED. THE ACETABULAR SHELL WAS CONFIRMED TO BE LOOSE AND WAS REVISED. DOI: (B)(6) 2008 - DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: No Code Available; Pain

  MAUDE report 9415975 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: ((B)(6) 2017) LEGAL DOCUMENTS RECEIVED. ALLEGES UNSPECIFIED INJURIES DUE TO THE IMPLANTATION OF PINNACLE PRODUCTS AND APPURTENANT PARTS. LINER AND HEAD REPORTED; PART AND LOT DETERMINED BY INVOICE. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES BONE FRACTURE, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. ADDED STEM AND UNKNOWN HIP IMPLANT DUE TO NEW ALLEGATION REPORTED FROM PPF. ADDED EXPIRATION DATE OF THE LINER AND HEAD. ADDED ACCOUNT NAME, LAW FIRM, REVISION AND EVENT DATE, PATIENT AGE, DATE OF BIRTH AND GENDER. DOI: (B)(6) 2007 - DOR: (B)(6) 2017 (RIGHT HIP, FIRST REVISION). PATIENT IS BILATERAL PLEASE SEE (B)(4) FOR THE LEFT HIP FIRST REVISION.

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

  MAUDE report 9401196 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR REPORTABILITY. PFS REPORTED DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, EMOTIONAL DISTRESS, CONSEQUENCES RELATED TO METAL ION EXPOSURE, PAIN, PAINFUL ITCHY RASH, DISLOCATIONS, HIP FRACTURE, CONFINED TO WHEELCHAIR, LOSS OF INDEPENDENCE AND HOMEBOUND. MEDICAL RECORDS AND REVISION SURGICAL REPORT NOTED POPPING, INSTABILITY, SEVERAL EPISODES OF SUBLUXATION, AND DEFICIENT ABDUCTORS. UPDATE AD 05 SEP 2018: COM-(B)(4) HAS BEEN RE-OPENED UNDER PC-(B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES PULMONARY EMBOLISM AND BONE FRACTURE. DOI: (B)(6) 2009 (LINER, HEAD, AND APEX HOLE ELIMINATOR) - DOR: (B)(6) 2010 (LEFT HIP). DOI: (B)(6) 2007 (CUP AND STEM). THIS PC IS FOR THE SECOND REVISION OF THE LEFT HIP. PLEASE SEE PC-(B)(4) FOR THE FIRST REVISION AND PC-(B)(4) FOR THE THIRD REVISION.

  Patient problems: Bone Fracture(s); Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Pulmonary Embolism; Test Result

  MAUDE report 9273847 ↗
• InjuryNov 4, 2019Adverse 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 (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: PATIENT HAD A REACTION TO METAL. UPDATE REC'D 5/19/2015: LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND DIFFICULTY WALKING. UPDATE 11/20/2015: PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS REVIEWED FOR REPORTABILITY. PFS REPORTED DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, EMOTIONAL DISTRESS, CONSEQUENCES RELATED TO METAL ION EXPOSURE, PAINFUL ITCHY RASH, DISLOCATIONS, HIP FRACTURE, CONFINED TO WHEELCHAIR, LOSS OF INDEPENDENCE AND HOMEBOUND. MEDICAL RECORDS AND REVISION SURGICAL REPORT NOTED SWELLING IN LEFT GROIN, LARGE FLUID COLLECTION, NECROSIS OF TISSUE AND MUSCLE, METAL REACTION AND WEAKNESS. THERE WERE NO LAB TESTS FOR METAL IONS WITHIN MEDICAL RECORDS REVIEWED. THERE WAS NO REPORT OF DISLOCATION OR HIP FRACTURE IN REVISION SURGICAL REPORT. UPDATE AD 05 SEP 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6)

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Edema; Hypersensitivity/Allergic reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Weakness

  MAUDE report 9273762 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, LOSS OF MOBILITY, AND LOSS OF RANGE OF MOTION. LITIGATION HAS ALSO PROVIDED A REVISION DATE OF (B)(6) 2015. AT THIS TIME, WE ARE UNAWARE WHAT PRODUCTS WERE REMOVED AND REASON FOR THE REVISION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT WILL BE UPDATED AT THAT TIME. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2015 .(LEFT HIP) FIRST REVISION.

  Patient problems: Discomfort; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Test Result

  MAUDE report 8932647 ↗
• InjuryAug 21, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8916498 ↗
• InjuryMay 7, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO REMOVE ASR PRODUCT. UPDATE: THE PATIENT WAS REVISED TO ADDRESS PAIN, HIP DYSFUNCTION, ELEVATED COBALT AND CHROMIUM METAL ION AND PRESENCE OF ABNORMAL FLUID COLLECTION. OPERATIVE NOTE REPORTED SOME MOVEMENT OF THE CUP AND MINIMAL BONE GROWTH BUT WAS NOT INDICATED TO HAVE BEEN LOOSE. THERE WERE NO LAB RESULT PROVIDED FOR THE ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: (B)(6) 2016; LEFT HIP.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8586362 ↗
• InjuryMar 6, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THAT PATIENT'S IMPLANT HAS RELEASED METAL IONS AND PARTICLES INTO PATIENT'S SYSTEM, CAUSING SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN, AS WELL AS A POPPING AND SNAPPING SENSATION IN THE HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED. PPF ALLEGES CONSTRAINED LINER, LOOSENING OF STEM AND INFECTION. DOI: (B)(6) 2006 - DOR: (B)(6) 2011 (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain; Unspecified Infection

  MAUDE report 8394264 ↗
• InjuryJan 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PULMONARY EMBOLISM. DOI : (B)(6) 2005 DOR: (B)(6) 2016 (RIGHT HIP).

  Patient problems: No Code Available; Pain; Pulmonary Embolism; Test Result; Tissue Damage

  MAUDE report 8267265 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PULMONARY EMBOLISM AND ELEVATED METAL IONS. DOI: (B)(6) 2003 - DOR: (B)(6) 2016 (LEFT HIP).

  Patient problems: No Code Available; Pain; Pulmonary Embolism; Test Result; Tissue Damage

  MAUDE report 8264035 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PATIENT'S ACETABULUM, CAUSED SEVERE PAIN, AND INHIBITED PATIENT'S ABILITY TO WALK. PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2012 (LEFT HIP).

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

  MAUDE report 8189501 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSE ACETABULAR CUP RELATED TO POOR BONE GROWTH. CUP WAS LOOSE AT BONE TO IMPLANT INTERFACE. LITIGATION ALLEGED FRICTION AND WEAR BETWEEN THE METAL HEAD AND LINER CAUSED THE RELEASE OF TOXIC METAL IONS AND PARTICLES INTO THE PATIENT'S BODY RESULTING TO INJURY ASSOCIATED WITH METALLOSIS, PAIN, DISCOMFORT, SORENESS, NEGATIVELY AFFECTING THE ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING, AND EMOTIONAL DISTRESS. DOI: UNKNOWN; DOR: (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8006766 ↗
• InjuryAug 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LITIGATION PAPERS ALLEGE: FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT CHROMIUM METAL LINER HAS CAUSED LARGE AMOUNTS OF TOXIC COBALT CHOMRIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER RIGHT LEG; POPPING AND CLICKING SOUND IN HER RIGHT HIP, SENSATION THAT THE PINNACLE DEVICE IS UNSTABLE AND WILL GIVE OUT ON HIM, INABILITY TO WALK MODERATE OR LONG DISTANCES, INABILITY TO SLEEP ON HER RIGHT SIDE WITHOUT SEVERE PAIN, INABILITY TO SIT FOR MODERATE TO LONG PERIODS OF TIME, METALLOSIS, COBALT CHROMIUM METAL TOXICITY AND OTHER COMPLICATIONS. DOI: (B)(6) 2003 - DOR: (B)(6) 2011 (RIGHT HIP). UPDATE (B)(6) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. UPDATED PATIENT'S INITIALS, AND NOTED THE PATIENT'S RESIDENCE. ADDED PATIENT'S DATE OF BIRTH AND ADDED THE FIRM NAME. ADDED ACCOUNT NAME/REVISION HOSPITAL. ADDED STEM 157002090 LOT # W4SFN1001. DOI: (B)(6) 2003 - DOR: (B)(6) 2011 (RIG

  Patient problems: Discomfort; Inflammation; Pain; Test Result; Tissue Damage

  MAUDE report 7784482 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PATIENT WAS REVISED TO DUE TO PAIN, AUDIBLE CLICKING SOUNDS, METALLOSIS, NUMBNESS, LOCKING OF THE HIP, AND OTHER COMPLICATIONS. UPDATE JUN 30, 2017: LITIGATION RECEIVED. AFTER REVIEW OF LITIGATION, THERE IS NO NEW INFORMATION ADDED THAT CHANGES THE MDR REPORTABILITY. THIS COMPLAINT WAS UPDATED ON: JUL 11, 2017. UPDATE JUL 05, 2017: LEGAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND SOFT TISSUE REACTION. ON HER LAST VISIT FROM (B)(6) 2016, THE PATIENT REQUESTED FOR BLOOD WORK WHICH DEMONSTRATED SLIGHTLY ELEVATED COBALT AND CHROMIUM LEVELS AND AN MRI WHICH DEMONSTRATED AN ADVERSE SOFT TISSUE REACTION WITH SUBSTANTIAL JOINT EFFUSION. ON THE REVISION NOTE IT WAS REPORTED THAT, WHEN THE HIP JOINT WAS EXPOSED, THERE WAS A METALLIC STAINED SYNOVIAL FLUID. A MILD-TO-MODERATE AMOUNT OF METALLIC DEBRIS STAINING AND SYNOVIAL. IN ADDITION, THE FEMORAL HEAD WAS REMOVED AND RETAIN THE STEM. CLINICAL NOTES STATE INFLAMMATION AROUND HIP. THERE WERE NO LABORATORY VALUES PROVIDED FOR THE COBALT/CHROMIUM. THIS COMPLAINT WAS UPDATED ON: JUL 13, 2017. UPDATE AD 1

  Patient problems: Hypoesthesia; Inflammation; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 7771999 ↗
• InjuryJul 25, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY AMBULATING. UPDATE: 5/21/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED BY INVOICE SEARCH. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. DOI: (B)(6) 2006 - DOR: NONE REPORTED (LEFT HIP). UPDATE AD 30 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF WITH STICKER SHEETS AND MEDICAL RECORDS. PPF ALLEGES ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, IT PROVIDED ONLY THE IMPLANT RECORD. THE EVENT DESCRIPTION HAS BEEN UPDATED TO INDICATE THE ALLEGATIONS AS REVIEWED. UPDATED PRODUCT DETAILS AND THE DATE OF REVISION. DOI: (B)(6) 2006 - DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 7718463 ↗