SUMMIT 1570-12-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295060215), received between Feb 25, 2019 and May 3, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 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 AND CLICKING. THERE WAS QUITE A BIT OF GRAYISH TISSUE SURROUNDING THE CAPSULE. UPDATE AD 10 APR 2019. RECEIPT OF MEDICAL RECORDS AND STICKER SHEETS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN, DISCOMFORT, SYMPTOMS OF IMPINGEMENT, CLICKING SOUNDS UPON LEG EXTENSION AND ELEVATED COBALT AND CHROMIUM LEVELS. OPERATIVE FINDINGS INCLUDE A SUBSTANTIAL AMOUNT OF JOINT FLUID EXTRUDED FROM THE JOINT, INFLAMMATION AND EXTENSIVE SCAR TISSUE. ADDED MEDICAL HISTORY, EXPIRATION DATES, PATIENT DATE OF BIRTH, PATIENT HARMS AND PRODUCT EXPERIENCE CODE FOR IMPINGEMENT, FEMORAL SLEEVE AND STEM. THIS COMPLAINT WAS UPDATED ON 23 APR 2019.

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

  MAUDE report 8577836 ↗
• InjuryFeb 25, 2019Adverse 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) 2016; (RIGHT HIP).

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

  MAUDE report 8366592 ↗