SUMMIT 1570-12-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295060123), received between Jan 28, 2019 and Apr 6, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Degraded” (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.

• InjuryApr 6, 2020Degraded; Degraded

  IT WAS REPORTED THAT PATIENT HAD INCREASING HIP & GROIN PAIN. HEAD & LINER EXCHANGE. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT PATIENT PRESENTS WITH PROGRESSIVE WEIGHT-BEARING PAIN AND SOME INTERMITTENT MECHANICAL SYMPTOMS OF CATCHING OR RATCHETING IN HER RIGHT HIP. HER EVALUATION REVEALED THAT SHE DID HAVE ELEVATED COBALT AND CHROMIUM ION LEVELS, AND AN MRI DID SHOW A MODERATE-SIZED PERIARTICULAR FLUID COLLECTION. THE PATIENT WAS THEN REVISED FOR FAILED RIGHT TOTAL HIP ARTHROPLASTY DUE TO METALLOSIS AND LOCAL ADVERSE TISSUE REACTION AS WELL AS EARLY PERIACETABULAR OSTEOLYSIS. OPERATIVE NOTES REPORTED THAT THERE WAS BLACKISH AND GRAYISH METALLOSIS STAINING WITHIN THE SYNOVIAL LINING DIFFUSELY OF THE HIP JOINT, AND THERE WAS SOME WEAR DEBRIS WITHIN THE CAPSULAR STRUCTURES. THERE WAS CLEAR TRUNNIONOSIS WITH WEAR DEBRIS AT THE JUNCTION OF THE FEMORAL HEAD AND THE TRUNNION. THERE WAS SOME MILD YELLOWISH WEAR DEBRIS ON THE POSTERIOR ASPECT OF THE LINER, SURGEON FELT THE MAJORITY OF THE METALLOSIS WEAR DEBRIS WAS FROM THE TRUNNION. THERE WAS EVIDENCE FOR SOME OSTEOLYSIS. DOI: (B)(6) 2007; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9928393 ↗
• InjuryJan 28, 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; DOR: (B)(6) 2017; (LEFT HIP).

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

  MAUDE report 8281255 ↗