SUMMIT 1570-05-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295059745), received between Oct 18, 2019 and Oct 31, 2019 — classified as 2 injuries.

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.

• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT HIP REVISION - PATIENT COMPLAINED OF HIP PAIN. ORIGINAL DATE OF SURGERY (B)(6) 2018 CONVERTED HEMI HIP TO TOTAL HIP - REMOVED STEM, CATHCART AND SLEEVE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, (B)(4). DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE, (B)(4). DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE, (B)(4). DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Code Available; Pain

  MAUDE report 9261935 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. REMOVED THE SUMMIT BASIC SZ 8 STEM AND 55MM BIPOLAR HEAD. AREA WASHED OUT. BROACH THE FEMUR WITH PROSTALAC BROACHES UP TO A SIZE 5. A SIZE 1 STANDARD OFFSET PROSTALAC STEM WAS OPENED AND CEMENT WAS THE CEMENT WERE PLACED IN THE SIZE 5 PROSTALAC MOLD. ONCE THE CEMENT WAS FULLY CURED, THE MOLD WAS TAKEN APART AND THE PROSTALAC STEM WAS IMPLANTED ALONG WITH A 56MM UNI POLAR HEAD AND +0 SLEEVE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9209258 ↗