SUMMIT 1570-05-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295059721), received between May 9, 2018 and Apr 26, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS A PERIPROSTHETIC FRACTURE. CONVERTED TO REVISION STEM. LOOSENING AT NON CEMENTED INTERFACE. NO SURGICAL DELAY. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 14205452 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE OF THE FEMUR. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 12096945 ↗
• InjuryJun 15, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. HEMI REVISION TO TOTAL HIP DUE TO FEMORAL STEM BECOMING LOOSE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11999460 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PERIPROSTHETIC FEMUR FRACTURE. THIS IS ALL THE INFORMATION AVAILABLE. DOI: (B)(6) 2017. DOR: (B)(6) 2021. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 11590074 ↗
• InjuryDec 22, 2020Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED BIPOLAR HIP CONSTRUCT TO ADDRESS PERIPROSTHETIC FEMORAL FRACTURE AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. SUMMIT BASIC STEM BIPOLAR CONSTRUCT WAS REMOVED AND REPLACED WITH A RECLAIM STEM AND BIPOLAR. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 11057121 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REMOVED THE STEM LISTED BELOW AND REPLACED IT WITH A NEW PRIMARY STEM AND USED 4 CABLES. PERI-PROSTHETIC FX WAS THE REASON FOR REVISION. NO OTHER INFO IS KNOWN AT THIS TIME. TO ANSWER THE QUESTION BELOW-NOTHING WAS BROKEN IN CASE/THEREFORE NOTHING REMOVED FROM THE PATIENT. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

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

  MAUDE report 10531886 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORDS RECEIVED. THERE WERE NO HARMS REPORTED. MEDICAL RECORDS PROVIDED THE PRIMARY SURGERY ONLY, THERE WERE NO REVISION NOTES INCLUDED. SHALL THERE BE NEW INFORMATION RECEIVED THIS COMPLAINT WILL BE UPDATED. DOI: (B)(6) 2008; DOR: NONE REPORTED; (RIGHT HIP).

  Patient problems: Adhesion(s); Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Scar Tissue; Test Result

  MAUDE report 9415966 ↗
• InjuryMar 26, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT FELL AND SUFFERED A RIGHT PERIPROSTHETIC FEMUR FRACTURE AND STEM LOOSENING AT THE BONE TO IMPLANT INTERFACE. THE BASIC STEM WAS REMOVED AND A LONG SOLUTION STEM AND CABLES WERE PLACED. DOI: (B)(6) 2018; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8453067 ↗
• InjuryMay 9, 2018Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE AND CONVERSION OF A UNIPOLAR HIP TO A TOTAL HIP DUE TO OA OF THE ACETABULUM. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP. NO SURGICAL DELAY.

  Patient problems: Arthritis; Inadequate Osseointegration; Not Applicable

  MAUDE report 7498490 ↗