SUMMIT 1570-03-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295059554), received between Aug 18, 2017 and Jul 7, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT DISLOCATED A BIPOLAR AND REVISED TO AN EMPHASIS DUAL MOBILITY. WHEN TRYING TO TAKE THE BIPOLAR HEAD OFF THE STEM, THE STEM WAS DISLODGED. THERE WAS NO FAILURE ON THIS PART OF THE IMPLANT. IT WAS NOTED THE CEMENT USED WAS NOT DEPUYSYNTHES CEMENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 25735769 ↗
• MalfunctionOct 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AIMING ARM/INSERTION HANDLE FOR TN-ADVANCED CAUSED SCREWS TO MISS THE NAIL. ISSUE WAS WITH TNA SUPRA-PATELLAR NAIL AIMING ARM AND INSERTION HANDLE ARE THE ISSUE. STILL EXPERIENCING PROBLEMS WITH THE PROXIMAL LOCKING HOLES BEING MISSED WHEN DRILLING THE MEDIAL-TO-LATERAL PROXIMAL LOCKING SCREWS. THE DRILL BIT IS CONSISTENTLY STRIKING THE NAIL, CAUSING VIBRATION THROUGHOUT THE CONSTRUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397976 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC FRACTURE OF HER HIP. THE SURGEON REMOVED ALL THE INDWELLING IMPLANTS AND REPLACED THEM WITH NEW IMPLANTS. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 23397391 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 23030722 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PAIN. BIPOLAR WAS CONVERTED TO TOTAL. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 18097216 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE AROUND A DEPUY CEMENTED HEMI. THERE WAS NO SURGICAL DELAY. THERE WAS LOOSENING REPORTED AT THE BONE/CEMENT INTERFACE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 16627571 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID AN IMPLANT EXCHANGE DUE TO INFECTION. THE SURGEON IMPLANTED A PROSTALAC IMPLANT. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13731889 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. DOI: UNKNOWN, DOR: (B)(6) , 2022, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Limb Fracture

  MAUDE report 13471724 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A PERIPROSTHETIC FRACTURE. SURGEON REMOVED STEM, HEAD, AND LINER. THE CUP REMAINED IMPLANTED. A NEW LINER AND STEM AND HEAD WERE IMPLANTED. DOI: (B)(6) 2014. DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 11776872 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. THE PATIENT'S ORIGINAL TOTAL HIP WAS DONE (B)(6) 2020 AND HE HAD AN I&D WASHOUT, HEAD LINER EXCHANGE, ON (B)(6) 2020. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 11691265 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BROKEN OFF THE GREATER TROCHANTER AND STEM WAS LOOSE AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2019, DOR: OCTOBER 27, 2020, RIGHT SIDE.

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

  MAUDE report 10830513 ↗
• InjuryJun 29, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE STEM AT UNKNOWN INTERFACE. IT WAS NOTED THAT THIS WAS DUE TO METAL ON METAL LINER. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7650996 ↗
• InjuryAug 18, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED.

  Patient problems: No Information

  MAUDE report 6804238 ↗