SUMMIT 1570-12-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295060147), received between May 1, 2015 and Jun 21, 2023 — classified as 14 injuries.

The most frequently reported specific device problem is “Biocompatibility” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RESECTION FOR INFECTION. DOI: (B)(6) 2013. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17170320 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF RECEIVED. PPF ALLEGES DISLOCATION, METAL WEAR, METALLOSIS, AND FRACTURE COMPONENT, THE UNKNOWN LINER, UNKNOWN HEAD, AND UNKNOWN COMPONENT WERE REPORTED TO THE IMPACTED PRODUCT DUE TO THE PPF ALLEGATIONS. DOI: (B)(6) 2012 - DOR: NONE REPORTED (RIGHT HIP). PLEASE SEE (B)(4) AND (B)(4) FOR THE LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Embolism/Embolus; Hypersensitivity/Allergic reaction; Inflammation; Joint Laxity; Pain; Pulmonary Embolism; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14653268 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT PATIENT BECAME INFECTED CAUSING SEPTIC LOOSENING ON THE CUP. CHRONIC INFECTION SO SURGEON REMOVED COMPONENTS AND PUT SPACER. DOI: (B)(6) 2016 DOR: (B)(6) 2021 UNKNOWN HIP.

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

  MAUDE report 11304114 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEGAL CLAIM RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN, STIFFNESS, DISCOMFORT, AND DIFFICULTY AMBULATING. ALSO ALLEGED IS EXCESSIVE LEVELS OF CHROMIUM AND COBALT. UPDATE 09/25/2013- PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB AND PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE AD 19 MAY 2020; (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED LEFT HIP PSEUDOTUMOR, INSTABILITY WITH METAL ON METAL HIP ARTHROPLASTY. PRIOR TO REVISION PATIENT ALLEGED DISLOCATION. OPERATIVE NOTES INDICATED SYNOVITIS WITHIN THE ACETABULUM, CHRONIC INFLAMMATION AND FIBROSIS WITH PSEUDOMEMBRANE FORMATION AND METALLOSIS. ADDED DATE OF REVISION, ACCOUNT NAME, AGE OF PATIENT, GTIN OF CUP AND HEAD, MEDICAL HISTORY AND CORRECTED DATE OF BIRTH. ALSO ADDED STEM AND SLEEVE IN IMPACTED PRODUCTS. DOI: (B)(6) 2010 DOR: (B)(6) 2020 LEFT HIP.

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Muscular Rigidity; No Code Available; Pain; Test Result

  MAUDE report 10111652 ↗
• InjuryMar 7, 2019Loss of Osseointegration; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES POST TRAUMATIC STRESS DISORDER, DEPRESSION, ANXIETY, INSOMIA, SPASM, CRAMPS, SWELLING, MUSCLE STRAIN, LIMPING, CONSTIPATION, FEAR, PANIC ATTACK, FALL AND IMPLANT DISLOCATION. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO FAILED RIGHT HIP ACETABULAR REVISION RESULTING TO PAIN. OPERATIVE NOTE REPORTED OSTEOLYSIS, THERE WAS ABUNDANT SYNOVIAL FLUID CLEAR AND AMBAR. THERE WERE NO INFECTION AND WEAR. SOME OXIDATION AND CAVITARY IN THE ACETABULUM AND MEDIALIZATION OF THE CUP. THERE WAS NO LOOSENING AT THE STEM AS PER MEDICAL RECORDS THE FEMORAL COMPONENT WAS SOLID. YEAR 2007 AND 2008 PATIENT SUFFERED FALL.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Depression; Discomfort; Fall; Inadequate Osseointegration; Joint Dislocation; Muscle Spasm(s); No Code Available; Osteolysis; Pain; Swelling

  MAUDE report 8398555 ↗
• InjuryJan 30, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECEIVED. LITIGATION ALLEGES INJURY, PAIN, METALLOSIS, PSEUDOTUMOR, AND DISLOCATION. DOI: (B)(6) 2006; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8288353 ↗
• InjuryJan 30, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECEIVED. LITIGATION ALLEGES INJURY, PAIN, PSEUDOTUMOR AND DISLOCATION. DOI: (B)(6) 2006; DOR: (B)(6) 2011; RIGHT HIP.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8288339 ↗
• InjuryNov 28, 2018Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES METALLOSIS, METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Burning Sensation; Confusion/ Disorientation; Cramp(s); Depression; Dizziness; Fall; Fatigue; Foreign Body Reaction; Headache; Hearing Impairment; Hypersensitivity/Allergic reaction; Hypoesthesia; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Rash; Seizures; Shaking/Tremors; Test Result; Tissue Damage; Visual Impairment

  MAUDE report 8109872 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PSEUDOTUMOR, FRACTURE, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result

  MAUDE report 8071550 ↗
• InjuryJul 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ASR REVISION, ASR XL - RIGHT, REASON(S) FOR REVISION: PAIN AND COBALT AND CHROMIUM: METALOSIS. UPDATE - MARKED AS LEGAL, ADDED KID NUMBER, FILED OUT MW FIELDS AND ADDED A SLEEVE. TAKEN FROM (B)(6) UPDATE DATED (B)(6) 2014. ADDITIONAL INFORMATION: PLEASE NOTE THIS COM HAS BEEN RE-OPENED TO ADD COBALT AND CHROMIUM: METALOSIS IN THE DESCRIPTION. NO ACTION ACTIVITY IS NEEDED AS THIS REVISION REASON WAS ALREADY ADDED IN THE DROP DOWN COMPLAINT CATEGORY PREVIOUSLY SO HAD ALREADY BEEN REPORTED. (B)(6). UPDATE AD (B)(6) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) BECAUSE OF A NEW ALERT RECEIVED. THERE ARE NO NEW OR ADDITIONAL INFORMATION INDICATED ON THIS UPDATE.¿

  Patient problems: Pain; Test Result; Tissue Damage

  MAUDE report 7698431 ↗
• InjuryFeb 14, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES WEAKNESS AND DIFFICULTY IN WALKING. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY. THE PATIENT WAS REVISED DUE TO INCREASING PAIN, DISCOMFORT IN HER LEFT HIP AND DIFFICULTY IN WALKING. MARS MRI DEMONSTRATED COMPLETE AVULSION OF THE LEFT GLUTEUS MEDIUS AND MINIMUS TENDON WITH A PSEUDOTUMOR. COBALT AND CHROMIUM LEVEL ARE ABOVE 7PPB.

  Patient problems: Ambulation or Postural Difficulties; Host-Tissue Reaction; Injury; Loss of Range of Motion; No Code Available; Pain; Weakness

  MAUDE report 7269629 ↗
• InjuryAug 28, 2017Adverse 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

  PATIENT WAS REVISED TO ADDRESS POLY WEAR, AND THE LINER WAS NOT FIXED IN THE CUP. UPDATE 31 JUL 2017: LITIGATION RECEIVED. LITIGATION ALLEGES DISCOMFORT, PAIN, STIFFNESS, LOSS OF MOTION, METAL TOXICITY, IMPLANT LOOSENING, METALLOSIS, NECROSIS, AND SOFT TISSUE DAMAGE. ADDED THE HEAD FOR METALLOSIS AND STEM FOR ELEVATED METAL IONS. ADDED THE COMPLAINANT INFORMATION.

  Patient problems: Discomfort; Muscular Rigidity; Necrosis; No Code Available; Pain

  MAUDE report 6824977 ↗
• InjuryAug 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2015: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED DUE TO SOFT TISSUE NECROSIS AND GRANULOMA FROM METAL ON METAL. CLINICAL NOTES REPORTED OF PAIN AND DISCOMFORT. MRI SHOWED A LARGE AMOUNT OF PERI-PROSTHETIC FLUID OVER THE GREATER TROCHANTER AND IN THE ANTERIOR HIP BURSA WHICH REPRESENTING ALVAL AND INDICATIVE OF REACTION TO METAL WEAR. X-RAY STATED THAT THERE IS A BONE HETEROTOPIC NEW BONE FORMATION LATERAL TO THE HIP AND ALSO NEW BONE FORMATION AT SUPEROMEDIAL ASPECT OF THE ACETABULAR CUP. LABORATORY RESULTS FOR COBALT WERE ABOVE 7PPB. PRODUCT CODES AND LOT NUMBERS PROVIDED.

  Patient problems: Discomfort; Pain

  MAUDE report 6762826 ↗
• InjuryMay 1, 2015Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT REVISED TO ADDRESS INFECTION. UPDATE 4/30/2015- PFS AND MEDICAL RECORDS RECEIVED. PFS AND MEDICAL RECORDS WERE RECEIVED ON 8/18/2014 WITH THE ALERT DATE OF (B)(6) 2013. THE RECORDS WERE REVIEWED FOR MDR REPORTABILITY ON 4/30/2015. PFS ALLEGES INFECTION AND THE MEDICAL RECORDS INDICATE THE PATIENT'S IMPLANTS WERE ALL REMOVED ON (B)(6) 2009 FOR INFECTION AND PROSTALAC WAS PLACED. THE STEM, HEAD, AND LINER THAT ARE ON THIS COMPLAINT ARE BEING CHANGED TO REPORTABLE NOW. THE CUP AND 2 SCREWS THAT WERE ALSO REMOVED ARE REPORTED ON (B)(4). AFTER THE PATIENT'S IMPLANTS WERE REMOVED ON (B)(6) 2009 THE PATIENT WENT THROUGH SEVERAL I&DS AND PROSTALAC CHANGES AND WAS REIMPLANTED ON (B)(6) 2009.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Embolism/Embolus; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Impaired Healing; Inflammation; Joint Laxity; Limb Fracture; Necrosis; Pain; Pulmonary Embolism; Seroma; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 4741745 ↗