SUMMIT 1570-06-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295059790), received between Dec 18, 2017 and Jun 13, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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. 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 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A SPACER PLACED. HIP WAS GROSSLY INFECTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22201747 ↗
• InjuryDec 6, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND BOARDED FOR A HIP IRRIGATION AND DEBRIDEMENT (I&D) WITH HEAD SWAP. WHILE DISLOCATING THE FEMUR THE DOCTOR NOTICED THE STEM MOVING. THE STEM WAS LOOSE. CEMENT MANTEL WAS REMOVED AND A NEW HEMI WAS PUT IN AFTER A WASH OUT WAS PERFORMED. (B)(6). AFFECTED SIDE: LEFT HIP

  Patient problems: Unspecified Infection

  MAUDE report 18277206 ↗
• InjuryApr 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT DISLOCATED AND STEM FELL OUT AS THE DOC REDUCED THE HIP. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9967863 ↗
• InjuryMar 6, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE STEM AT CEMENT TO IMPLANT INTERFACE. ALL PARTS WHERE REMOVED. COMPETITOR STEM WAS USED. DOI: (B)(6) 2018. DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8394628 ↗
• InjuryJun 6, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  DER STATES THAT THIS PATIENT'S FEMORAL STEM WAS REVISED, FROM A SUMMIT BASIC CEMENTED STEM TO AN 8" SOLUTION STEM, DUE TO A PERIPROSTHETIC FRACTURE OF THE PROXIMAL FEMUR. THE PERIPROSTHETIC FRACTURE OCCURRED DURING THE IMPLANTATION OF THE PRIMARY STEM SIX DAYS EARLIER. THE SCRUB TECH INITIALLY MIXED A INSUFFICIENT AMOUNT OF BONE CEMENT FOR THE IMPLANTATION OF THE SUMMIT BASIC STEM. BY THE TIME A SECOND BATCH OF CEMENT WAS MIXED AND INSERTED INTO THE PATIENT'S FEMORAL CANAL, THE INITIAL CEMENT HAD ALREADY BEGUN TO HARDEN. DURING THE SURGEON'S ATTEMPT THE DRIVE THE STEM DISTALLY THROUGH THE HARDENING CEMENT, THE DISTAL TIP OF THE STEM BROKE THROUGH THE SIDE WALL OF THE FEMUR. A DISTALLY FIXED STEM WAS USED DURING THIS REVISION PROCEDURE TO REPLACEMENT THE ORIGINAL CEMENTED STEM. A REPLACEMENT BI-POLAR FEMORAL HEAD WAS ALSO UTILIZED DURING THE REVISION PROCEDURE. IT WAS ALSO STATED THAT THE STEM WAS LOOSE AT UNKNOWN INTERFACE AND A DEPUY CEMENT WAS USED. DOI: (B)(6) 2015; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7575159 ↗
• InjuryDec 18, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  DER STATES PT HAD ORIGINAL SURGERY (B)(6) 2017. ON (B)(6) 2017 PT HAD HEAD AND LINER EXCHANGE FOR INFECTION. PT STILL INFECTED SO SURGEON REMOVED ALL COMPONENTS AND PUT IN ANTIBIOTIC SPACER. IT ALSO STATE THAT PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT IS USED. DOI: (B)(6) 2017; DOR: (B)(6) 2017; HEAD AND LINER: (B)(6) 2017; LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7125117 ↗