SUMMIT 1570-05-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295059714), received between Sep 11, 2017 and Dec 16, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR FALL AND FRACTURE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23817634 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE FEMUR AROUND HIP STEM MAKING IT LOOSE, SO REPLACED STEM WITH A REVISION STEM. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 21170748 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17741236 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL, PPFX AROUND STEM. REVISED TO PLATE, SCREWS, CABLES AND RECLAIM. NO LOTS NUMBERS IN HOSPITAL RECORD, UNABLE TO GET LOT OFF EXPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2022. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 16157303 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LOOSE BIPOLAR CONVERT TO THA. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort; Pain

  MAUDE report 15896637 ↗
• InjuryMay 31, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM AT BONE TO IMPLANT INTERFACE. IT WAS REMOVAL OF LOOSE SUMMIT BASIC BIPOLAR HEMIARTHROPLASTY CONSTRUCT. NEW STEM WAS IMPLANTED WITH A PINNACLE CUP CONSTRUCT. DOI: (B)(6) 2020. DOI: (B)(6) 2022. AFFECTED SIDE- LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14549329 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PERI-PROSTHETIC FRACTURE. REVISION TO A LONG CEMENTED STEM. DOI: (B)(6) 2019, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 12691509 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BIPOLAR HIP IN 2012 AT THIS HOSPITAL. PATIENT PRESENTED WITH A PERI-PROSTHETIC FRACTURE AROUND STEM. CONVERTED TO A RECLAIM AND PINNACLE DUAL MOBILITY. DOI: 2012, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 12546455 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2018. RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 8137544 ↗
• InjuryNov 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8068764 ↗
• InjuryOct 16, 2018Loss of Osseointegration; Loss of Osseointegration

  THE STEM WAS FOUND TO BE LOOSE AT THE BONE TO IMPLANT INTERFACE AND SUBSEQUENTLY REVISED.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 7969060 ↗
• InjuryDec 12, 2017Loss of Osseointegration; Loss of Osseointegration

  DER STATES THAT THE PATIENT REVISED HEMIARTHROPLASTY TO TOTAL HIP ARTHROPLASTY. IT WAS ALSO REPORTED THAT THERE WAS A LOOSENING AT THE FEMORAL STEM AT THE BONE-IMPLANT INTERFACE. DOR: (B)(6) 2017. RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7108200 ↗
• InjurySep 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTHETIC FEMORAL BONE FRACTURE OF HEMI HIP AND IMPLANTS REMOVED. IT WAS ALSO REPORTED THAT THIS WAS DUE TO NATURAL PROGRESSION.

  Patient problems: Bone Fracture(s)

  MAUDE report 6855542 ↗