SUMMIT 1570-02-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295059455), received between Nov 20, 2017 and Feb 21, 2024 — classified as 36 injuries.

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 36 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A COMPLEX REVISION RIGHT TOTAL HIP ARTHROPLASTY, RADICAL RESECTION OF SCAR, TO ADDRESS RIGHT HIP ASEPTIC LOOSENING, RIGHT HIP PAIN, DAILY ACTIVITIES OF LIFE IMPAIRED AND LIMPING. OPERATIVE NOTE REPORTED SEVERE ARTHROSIS. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT HIP SECOND REVISION.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain; Scar Tissue

  MAUDE report 18746804 ↗
• InjuryJun 29, 2023Use of Device Problem; Use of Device Problem

  PINNACLE LINER REVISED FOR CHRONIC DISLOCATION. LINER AND HEAD REMOVED AD REPLACED WITH PINNACLE DUAL MOBILITY. YELLOW DISCOLORATION NOTED ON LINER WHEN REMOVED. NO NOTABLE WEAR ASSOCIATED WITH LINER AND IT REMAINED INTACT APART FROM DISCOLORATION. DOI: UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 17225458 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2022, THE PATIENT REPORTS HAVING BACK PAIN, RIGHT HIP PAIN, AND RIGHT LEG PAIN. ON (B)(6) 2023, THE PATIENT REPORTS HAVING PAIN IN LOWER BACK, WITH RADIATION TO THE RIGHT GROIN. THERE IS ASSOCIATED CHRONIC RIGHT LEG WEAKNESS CONTINUE TO WORSEN AND BILATERAL FEET NUMBNESS AND TINGLING. PATIENT HAS COMPLETED EXTENSIVE PHYSICAL THERAPY. DOI: (B)(6) 2009 (CUP AND STEM); DOI: (B)(6) 2022 (HEAD AND LINER); DOE: (B)(6) 2022; RIGHT HIP.

  Patient problems: Fatigue; Inflammation; Numbness; Pain

  MAUDE report 16888040 ↗
• InjuryMay 7, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION COMPLAINT RECEIVED AD 13 APR 2022. PATIENT WAS REVISED WAS DUE TO HEAVY METAL POISONING FROM TOXIC HEAVY METALS. ALSO ALLEGES INJURY, PAIN, DISLOCATIONS, PSEUDOTUMOR, MUSCLE AND TISSUE DESTRUCTION, METALLOSIS, METAL WEAR, LOSS OF ENJOYMENT OF LIFE AND LIMITATION OF DAILY ACTIVITIES. DOI: (B)(6) 2009. DOR: (B)(6) 2021. UNK HIP.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Depression; Extraskeletal ossification; Fibrosis; Foreign Body Reaction; Hematoma; Hypersensitivity/Allergic reaction; Inflammation; Joint Dislocation; Loss of Range of Motion; Metal Related Pathology; Necrosis; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14315650 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO METALLOSIS. DOI: (B)(6) 2009. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 13257689 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  21.12.05 PRIMARY HIP OPERATION. IMPLANTS USED: 58MM 100 PINNACLE CUP, HOLE ELIMINATOR, METAL INSERT, SIZE 4 SUMMIT STEM, 36 + 8.5 METAL ON METAL HEAD. PT PRESENTED WITH GROIN PAIN AND ELEVATED METAL ION LEVELS. PT REVISED TODAY ¿ HEAD AND LINER AND HOLE ELIMINATOR REMOVED. SAME REPLACED WITH POLY LIPPED LINER FOR 58MM CUP, HOLE ELIMINATOR AND A TS CERAMIC 36+8.5 HEAD. XRAYS TO FOLLOW AND PICTURE OF THE LINER REMOVED.

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

  MAUDE report 12468066 ↗
• InjuryNov 3, 2020Migration; Migration

  IT WAS REPORTED THAT THE DUE TO A PATIENT FALL, THE STEM SUBSIDED. STEM AND HEAD WERE REMOVED. CUP, LINER AND SCREW REMAINED IN PATIENT. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Fall; No Code Available

  MAUDE report 10778308 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS METAL ON METAL. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT HIP.

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

  MAUDE report 10650035 ↗
• InjuryJul 14, 2020Corroded; Degraded; Corroded; Degraded

  LITIGATION ALLEGED THAT PATIENT SUFFER FROM DEFECTS THAT CAUSE EXCESSIVE AMOUNT OF COBALT AND CHROMIUM TO WEAR FROM THE SURFACE OF THE ACETABULAR INSERT AND FROM THE FEMORAL HEAD, WHICH CAUSES THE SURROUNDING TISSUE AND BONE TO DIE. UPDATED FACILITY NAME AND ADDED ASSOCIATED CONTACT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fibrosis; Foreign Body Reaction; Necrosis; No Code Available; Pain; Test Result; Unspecified Tissue Injury

  MAUDE report 10269101 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10081044 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT HAD BILATERAL HIP PAIN. THE PATIENT WAS THEN REVISED FOR LEFT-SIDED HIP PAIN AND ELEVATED METAL ION LEVELS CONCERNING FOR METALLOSIS. OPERATIVE NOTES REPORTED THAT THERE WAS A SMALL PSEUDOTUMOR THAT HAD A VERY LITTLE AMOUNT OF FLUID. BONY OVERGROWTH OVER THE ACETABULAR COMPONENT WAS REMOVED AND THE ACETABULAR COMPONENT WAS RETROVERTED. DOI: (B)(6) 2005; DOR: (B)(6) 2018; LEFT HIP. THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR THE RIGHT HIP

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

  MAUDE report 9786162 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HIP JOINT PAIN. IT WAS ALSO INDICATED THAT THE SURGEON ELECTED TO REMOVE THE METAL INSERT AND FEMORAL HEAD AND EXCHANGE IT WITH A COP BEARING CONSTRUCT . THIS OPTION WAS EXECUTED FLAWLESSLY. THERE WERE NOT ANY INTEROPERATIVE ISSUES WITH THIS PROCEDURE. THE EXPLANTED COMPONENTS WERE RETAINED BY THE PATIENT'S ATTORNEY. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP. NO SURGICAL DELAY.

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

  MAUDE report 9574997 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PRIMARY HIP HARDWARE REMOVED AND REVISED WITH A PROSTALAC HIP SPACER DUE TO INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019, (UNKNOWN HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9553697 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, IMPLANT RECORDS AND STICKER SHEETS RECEIVED. PPF ALLEGED METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) "200"- DOR: NOT REPORTED, (LEFT HIP). SEE (B)(4) RIGHT HIP.

  Patient problems: Foreign Body Reaction; Test Result

  MAUDE report 8910269 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS ALLEGES PAIN, DISCOMFORT, SORENESS, DIFFICULTY WALKING AND STANDING, DIFFICULTY SLEEPING, LIMITED MOBILITY ANXIETY, UNNECESSARY SURGERY AND MUSCLE AND SOFT TISSUE DESTRUCTION. ADDED LAWYER AND LAW FIRM. UPDATED DOI. DOI: (B)(6) 2007. DOR: (B)(6) 2016, (RIGHT HIP).

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

  MAUDE report 8901274 ↗
• InjuryAug 14, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD HEMI ARTHROPLASTY HIP ON (B)(6) 2019. SHE FELL ON (B)(6) 2019 AND HAD A FRACTURE AROUND HER STEM, SURGEON PULLED STEM AND WENT WITH 8 INCH AML. HER ORIGINAL PAPERWORK IS (B)(4). DOR: (B)(6) 2019; RIGHT HIP.

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

  MAUDE report 8893293 ↗
• InjuryAug 2, 2019Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD SUMMIT STEM IN WHICH SUBSIDED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8856488 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR ORIGINAL COMPLAINT.- LITIGATION PAPERS ALLEGE DAMAGE TO THE PATIENT'S HIP JOINT AND HER BODY. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS, METAL WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAINFUL METAL ON METAL TOTAL HIP ARTHROPLASTY, LEFT HIP, WITH ELEVATED COBALT AND CHROMIUM LEVELS. DOI: (B)(6) 2004 - DOR: (B)(6) 2012 (LEFT HIP).

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

  MAUDE report 8722238 ↗
• InjuryJun 11, 2019Adverse 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 THE PATIENT WAS REVISED TO ADDRESS SURGICAL SITE INFECTION. OPERATIVE NOTE REPORTED A SMALL VOLUME OF SEROPURULENT FLUID AND NOTED TO EGRESS FROM BENEATH THE GLUTEUS MAXIMUS. DOI: (B)(6) 2010; DOR: (B)(6) 2010; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8687267 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: (B)(6) 2015, (LEFT HIP) FIRST REVISION. PATIENT IS BILATERAL PLEASE SEE (B)(4) FOR RIGHT HIP.

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

  MAUDE report 8575180 ↗
• InjuryApr 24, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2014, (RIGHT HIP); FIRST REVISION.

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

  MAUDE report 8543871 ↗
• InjuryApr 23, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS PAIN AND CUP MALPOSITIONING. UPDATE REC'D 9/17/15 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM WEAKNESS. UPDATE 1/31/17- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, MALPOSITIONED CUP (50 DEGREES ABDUCTION), NORMAL COBALT/CHROMIUM LEVELS, AND DISLOCATIONS/SUBLUXATIONS. UPDATE AD 01 APR 2019: RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGE ELEVATED METAL IONS.

  Patient problems: No Code Available; Pain; Test Result; Weakness

  MAUDE report 8539384 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8270562 ↗
• InjuryJan 4, 2019Biocompatibility; Biocompatibility

  PPF AND STICKER SHEETS RECEIVED. PPF HAS NO NEW ALLEGATIONS REPORTED. BLOOD HEAVY METAL IS CODED DUE TO THE LEFT HIP HAVING RELEASED METAL IONS "ON" THE BODY.

  Patient problems: Test Result

  MAUDE report 8217555 ↗
• InjuryJan 3, 2019Loss of Osseointegration; Loss of Osseointegration

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM ELEVATED LEVELS OF CHROMIUM AND COBALT, PAIN AND TISSUE INFLAMMATION. PPF ALLEGES LOOSENING OF CUP AND LOOSENING OF STEM. DOI: (B)(6) 2010; DOR: (B)(6) 2013; (LEFT HIP).

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

  MAUDE report 8212060 ↗