SUMMIT 1570-02-165Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295059509), received between Mar 22, 2019 and Jun 23, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE FROM A FALL. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 17189964 ↗
• InjuryJul 6, 2021Naturally Worn; Naturally Worn

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALOSIS AND ELEVATED METAL IONS. OPERATIVE NOTE REPORTED METAL DEBRIS AROUND THE TRUNNION. THERE WERE TINY SCRATCHES COVERING THE SURFACE OF THE FEMORAL HEAD. DARKENING OF THE TISSUES CONSISTENT WITH METALOSIS WERE SEEN. THERE WAS A LARGE AREA OF OSTEOLYSIS IN THE ACETABULUM. LINER WAS FOUND TO HAVE A VERY TINY SCRATCHES AND SOFT TISSUE AND THIS WAS SENT FOR PATHOLOGY. TOTAL EXTRACTION OF THE LINER FROM THE CUP TOOK OVER AN HOUR. DOI: (B)(6) 2010; DOR: (B)(6) 2021 ; LEFT HIP.

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

  MAUDE report 12121675 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 11843439 ↗
• InjuryDec 21, 2020Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND EFFUSION. 1.5 36 METAL BALL AND 9 STD SUMMIT NECK TAPER DEVELOPED TAPER CORROSION AND SUBSEQUENT METALLOSIS OF TISSUES REPLACED COCR BALL WITH TS DELTA +5 BALL. DOI: (B)(6) 2016. DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 11050524 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUSTAINED A PERIPROSTHETIC FRACTURE AND HAD REVISION FOR HARDWARE REMOVAL WITH A REIMPLANTATION OF A CEMENTED SUMMIT FEMORAL STEM AND POLY LINER. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

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

  MAUDE report 10158037 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS METALLOSIS. UPDATE PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE UPON REVISION A PSEUDOTUMOR AND ADVERSE LOCAL TISSUE REACTION WAS FOUND. NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ABDUCTOR MUSCLE REPAIR AND ELEVATED METAL IONS. DOI: (B)(6) 2005, DOR: (B)(6) 2012, (RIGHT HIP).

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

  MAUDE report 8443814 ↗