SUMMIT 1570-12-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295060130), received between Feb 25, 2015 and Aug 6, 2019 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION, ELEVATED METAL IONS AND BONE FRACTURE. THE UNKNOWN HIP IMPLANT HAS BEEN ADDED TO CAPTURED THE ALLEGATION OF A FRACTURE AS ITS UNKNOWN WHERE THE FRACTURE WAS. DOI: (B)(6) 2008 (STEM); DOI: (B)(6) 2011 (HEAD AND LINER), DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: No Code Available; Test Result

  MAUDE report 8866080 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR AND METALLOSIS.

  Patient problems: Host-Tissue Reaction; No Code Available; Pain; Test Result

  MAUDE report 8486786 ↗
• InjuryApr 3, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE: 7/31/2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES DISCOMFORT AND METALLOSIS. UPDATE REC'D 12/18/2013- PFS AND MEDICAL RECORDS RECEIVED. A POST-OP X-RAY SHOWED THE MOST LATERAL SCREW TO BE PROUD. A SCREW HAS NOW BEEN REPORTED. REVISION OPERATIVE NOTES INDICATED SYNOVITS AND CONFIRMED METALLOSIS. RIGHT SIDE WAS ALSO INDICATED. UPDATE AD 25 JUL 2018 - (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND IMPLANT RECORD. PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result

  MAUDE report 8477872 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PSEUDOTUMOR, DISLOCATION AND ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8320080 ↗
• InjuryFeb 8, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF DISLOCATION. UPDATE AD 08 MAY 2018RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS. DOI: (B)(6) 2011, DOR: (B)(6) 2011, (LEFT HIP) 2ND REVISION.

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

  MAUDE report 8319934 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES DISLOCATION WITH CLOSED REDUCTION, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8222399 ↗
• InjuryJan 4, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES PAIN AND SUFFERING. UPDATE REC¿D 2/3/2014 - PFS WAS RECEIVED FROM LEGAL, PRIMARY AND REVISION MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF PAIN AND "METALOSIS". UPDATE AD 04 MAY 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 DISLOCATION WITH CLOSED REDUCTION, METAL WEAR AND ELEVATED METAL IONS.

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

  MAUDE report 8217021 ↗
• InjuryNov 21, 2018Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE: PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, HIGH LEVELS OF TOXIC METAL IN HER BLOOD STREAM, AND CONSCIOUS PAIN. UPDATE AD 29 MAY 2018: RECEIPT OF PPF AND MEDICAL RECORD RECEIVED. PPF ALLEGES METAL WEAR, METALLOSIS, ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS METALLOSIS.

  Patient problems: No Code Available; Test Result

  MAUDE report 8094247 ↗
• InjuryNov 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF RECEIVED. PPF ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8055377 ↗
• InjuryFeb 25, 2015Osseointegration Problem; Insufficient Device Problem Information; Noise, Audible

  (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2006, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE DEVICE WITH AN ULTAMET LINER ON HER LEFT SIDE. AFTER THE SURGERY, LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES WERE RELEASED INTO PATIENT'S BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN HER THIGH, KNEE, GROIN AND HIP-JOINT; THE FORMATION OF METALLOSIS AND PSEUDOTUMORS IN AND AROUND THE HIP-JOINT; AN INABILITY TO WALK MORE THAN FIFTY YARDS; INABILITY TO CLIMB STAIRS; INABILITY TO SIT OR STAND FOR PROLONGED PERIODS OF TIMES; INABILITY TO STOOP OR BEND WITHOUT EXCRUCIATING PAIN; INABILITY TO SLEEP FOR MORE THAN TWO HOURS CONSECUTIVELY WITHOUT AWAKENING IN PAIN; REDUCED RANGE OF MOTION; CLICKING SOUND AND SENSATION EMANATING FROM THE HIP-JOINT; AND OTHER COMPLICATIONS. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT. UPDATE (B)(4) 2015 - DISC 209 PFS AND MEDICAL RECORDS RECEIVED. PFS IDENTIFIED PATIENT DOR, DOB, HEIGHT AND WEIGHT. AN UNKNOWN STEM IS BEING ADDED TO ADDRESS PREVIOUS ALLEGATIONS OF ELEVATED TOXIC METAL I

  Patient problems: Discomfort; Inflammation; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 4546940 ↗