SUMMIT 1570-02-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295059479), received between Jul 31, 2017 and Jun 30, 2023 — classified as 1 death, 34 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (6 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THAT PATIENT SUFFERED A PERIPROSTHETIC FRACTURE TO UNKNOWN HIP SIDE. THE DATES OF FRACTURE AND REVISION ARE UNKNOWN. THIS REPORT IS FOR SUMMIT DUOFIX TAP SZ6 STD OFF. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Limb Fracture

  MAUDE report 17240681 ↗
• InjuryMay 15, 2023Naturally Worn; Naturally Worn

  PATIENT METAL HIP BALL WAS REVISED DO TO PAIN AND ELEVATED COCR LEVELS. REVISED AND FOUND HEAD AND TAPER HAD BLACK DEBRIS DUES TO TRUNIONOSIS. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain

  MAUDE report 16933621 ↗
• InjuryOct 12, 2022Degraded; Degraded

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES INJURY AND PAIN. DOI: (B)(6) 2008 : DOR: (B)(6) 2020 . (LEFT HIP).

  Patient problems: Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 15587240 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ASR CUP REVISION DUE TO METALOSIS. DOI: (B)(6), 2009, DOR: (B)(6) 2020 LEFT HIP.

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

  MAUDE report 14161135 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED AND STATED THE FOLLOWING: ON (B)(6) 2021. PATIENT WAS REVISED TO FAILED RIGHT TOTAL HIP REPLACEMENT ASSOCIATED WITH ADVERSE REACTION TO METALLIC DEBRIS, PROXIMAL FEMORAL OSTEOLYSIS, AND COMMINUTED FRACTURE RIGHT GREATER TROCHANTER. OPERATIVE INDICATED THAT THE CAT SCAN SHOWED PATIENT'S CUP POSITION WAS 56 DEGREES OF ABDUCTION AND 48 DEGREES ANTEVERSION. COBALT CHROMIUM ION LEVELS AND ADVERSE TISSUE REACTION TO METALLIC DEBRIS AND AN OSTEOLYTIC INDUCED FRACTURE OF THE GREATER TROCHANTER.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Distress; Extraskeletal ossification; Limb Fracture; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 11743895 ↗
• MalfunctionDec 9, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE SURGEON WANTS THIS SIZE SIX STD SUMMIT DUOFIX MEASURED AND REPORTED BACK TO HIM IF IT WAS WITHIN TOLERANCES. HE BROACHED TO A SIZE SIX BUT WHEN HE WENT TO IMPLANT THE STEM IT WAS 5 MM PROUD. HE THEN TRIED TO USE THREADED INSERTER AND IT CROSS THREADED. HAD TO USE A CLAMP ON STYLE ALSO HAMMER WHICH DAMAGED THE TAPER. A SECOND SIZE SIX STANDARD WAS THEN OPENED AFTER RE BROACHING. IT WAS IMPLANTED WITH OUT FURTHER PROBLEMS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10975608 ↗
• InjuryOct 22, 2020Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  REVISION OF DEPUY SYNTHES PRODUCTS. SUMMIT STEM AND HEAD WAS REMOVED AS THE STEM WAS LOOSE AND HAD SUBSIDED. NOT DUE TO INFECTION. DURALOC CUP WITH TWO SCREWS AND LINER WERE REMOVED. NEW ACETABULAR COMPONENTS WERE IMPLANTED.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 10719263 ↗
• MalfunctionFeb 11, 2020Contamination /Decontamination Problem; Difficult to Open or Remove Packaging Material; Contamination /Decontamination Problem; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE STEM IS OPENED AND INNER PACKAGE LOOKED UNUSUAL SO IT WAS NOT IMPLANTED. DOE: (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9693331 ↗
• InjuryDec 27, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED ALL IMPLANTS FOR INFECTION AND LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE. SURGEON PLACED A PROSTALAC HIP STEM AND ACETABULAR CUP. DOI: (B)(6) 2014. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Unspecified Infection

  MAUDE report 9525769 ↗
• InjuryNov 12, 2019Corroded; Degraded; Corroded; Degraded

  LITIGATION ALLEGES PAIN AND ELEVATED METAL ION LEVELS. UPDATE 25 SEP 2018 (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PFS AND MEDICAL RECORDS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PFS ALLEGES PSEUDOTUMOR, METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, OPERATIVE FINDINGS CLOUDY FLUID THROUGHOUT THE HIP, PSEUDOTUMOR WITH GREENISH-GRAYISH MEMBRANE, VERY MILD CORROSION AT THE TRUNNION AND ANTEVERSION CUP. DOI: (B)(6) 2008; DOR: (B)(6) 2013; RIGHT HIP.

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

  MAUDE report 9312298 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES SHARP PAIN, DISCOMFORT, LOCAL TISSUE REACTION, AND INJURY. PATIENT'S ORTHOPAEDIC SURGEON RECOMMENDED REVISION SURGERY. DOI: (B)(6) 2009; DOE: (B)(6) 2017; DOR (NOT REPORTED); RIGHT HIP.

  Patient problems: Discomfort; Fibrosis; Foreign Body Reaction; Injury; No Code Available; Pain

  MAUDE report 9309942 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND MEDICAL RECORD. PPF ALLEGES STROKE/HEART ATTACK AND PULMONARY EMBOLISM. DOI: (B)(6) 2014 (HEAD AND LINER) ; DOI: (B)(6) 2007 (CUP, SCREWS, APEX AND STEM). DOR: NONE REPORTED (LEFT HIP). THE PATIENT IS BILATERAL. PLEASE SEE PC-(B)(4) FOR RIGHT HIP.

  Patient problems: Cardiac Arrest; Infarction, Cerebral; Pulmonary Embolism

  MAUDE report 8946435 ↗
• InjuryJul 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR ORIGINAL COMPLAINT. CLINICAL REPORT STATES THE PATIENT HAD PAIN. DOI: (B)(6) 2006, NO REVISION AT THIS TIME. (LEFT HIP). REPORT FROM SALES REP, THE PATIENT WAS REVISED BECAUSE OF PAIN AND METALLOSIS. DOR: (B)(6) 2012. LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: (B)(6) 2012, (LEFT HIP).

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

  MAUDE report 8776753 ↗
• DeathMay 7, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, ELEVATED COBALT LEVELS AND DISCOMFORT AS A RESULT OF THE IMPLANTED ASR HIP. UPDATE THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL IONS WHICH CONTRIBUTED TO HIS HEART AND LIVER CONDITIONS. THERE WERE NO LAB RESULTS PROVIDED FOR THE ALLEGED ELEVATED METAL IONS; HOWEVER, PATIENT WAS NOTED TO HAVE DECEASED BASE ON THE DEATH EXAM NOTE AND PHYSICAL EXAM NOTE ON (B)(6) 2018. DOI: (B)(6) 2008; DOR: (B)(6) 2018; RIGHT HIP.

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

  MAUDE report 8586230 ↗
• 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) 2009 (STEM); DOI: (B)(6) 2009 (HEAD,LINER AND CUP); DOR: (B)(6) 2009 (LEFT HIP).

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

  MAUDE report 8518734 ↗
• InjuryMar 29, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES LIMITED MOBILITY AND WEAKNESS. DOI: (B)(6) 2008 (LINER & HEAD). DOI: (B)(6)2006 (CUP, SCREW AND STEM). DOR: NONE REPORTED RIGHT HIP.

  Patient problems: Cardiac Arrest; Discomfort; Infarction, Cerebral; Limited Mobility Of The Implanted Joint; Myocardial Infarction; No Code Available; Pain; Stroke/CVA; Test Result; Weakness

  MAUDE report 8463875 ↗
• InjuryMar 21, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8439294 ↗
• InjuryMar 14, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, POPPING, AND STIFFNESS. UPDATE: (B)(6) 2013- SALES REP REPORTED REVISION SURGERY ON LEFT HIP DUE TO PAIN. UPDATE AD 29 JUN 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

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

  MAUDE report 8421002 ↗
• InjuryFeb 27, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: Test Result

  MAUDE report 8375487 ↗
• InjuryJan 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: NONE REPORTED (LEFT HIP).

  Patient problems: Injury; Test Result

  MAUDE report 8253064 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION MULTIPLE TIMES.

  Patient problems: No Code Available

  MAUDE report 8244069 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AND ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: (B)(6) 2017 (RIGHT HIP).

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

  MAUDE report 8189828 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES LARGE AMOUNTS OF METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2010 (RIGHT HIP).

  Patient problems: No Code Available; Pain; Tissue Damage

  MAUDE report 8174682 ↗
• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL RESULTING IN A FRACTURED FEMUR.

  Patient problems: No Code Available

  MAUDE report 8073273 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL REPORT STATES THAT PATIENT WAS REVISED TO ADDRESS DISLOCATION. LITIGATION PAPERS ALLEGE THAT AFTER THE SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT THE PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND GROIN. ADDITIONALLY THE PATIENT EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE: PPF ALLEGES METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2012 (LEFT HIP).

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

  MAUDE report 8055952 ↗