SUMMIT 1570-05-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295059707), received between Jul 21, 2017 and Nov 22, 2024 — classified as 22 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Migration; Migration

  IT WAS REPORTED, THAT THE PATIENT WAS REVISED TO A TOTAL HIP AS THE STEM SUBSIDED. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 20764859 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT FELL AND EXPERIENCED A PERIPROSTHETIC FRACTURE. THERE IS NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 20544443 ↗
• InjuryOct 17, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, ATTEMPTED REDUCTION OF DISLOCATED RIGHT HIP IN ER RESULTED IN ROTATION OF ENTIRE PROSTHESIS (STEM AND UNIPOLAR HEAD) IN THE FEMORAL CANAL AND HIP JOINT. NO RESULTING FEMORAL FRACTURE. IMPLANTS WERE PULLED AND REPLACED WITH REVISION TOTAL HIP COMPONENTS. THERE WAS LOOSENING OF STEM. LOOSENING INTERFACE IS NON-CEMENTED. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17948344 ↗
• InjuryJan 5, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS A CONVERSION FROM BIPOLAR CONSTRUCT TO TOTAL HIP REPLACEMENT. FEMORAL COMPONENT AND BIPOLAR WERE REMOVED AND REPLACED WITH A RECLAIM/PINNACLE CONSTRUCT. THERE WAS A LOOSENING OF STEM AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16104954 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUFFERED FALL AT HOME WITH PERIPROSTHETIC FRACTURE. HIP REVISED TO SOLUTION STEM. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14985905 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PERI-PROSTHETIC FEMUR FRACTURE AROUND A DEPUY STEM/HEMI. CABLED AND REVISED TO A SOLUTION STEM. DOI: (B)(6) 2015; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 13426058 ↗
• InjuryDec 20, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2021-DOR: (B)(6) 2021(UNK HIP). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021 IN RESPONSE TO: "WITH REGARDS TO THIS, PLEASE CONFIRM IF ANY OF THE FOLLOWING INFORMATION IS AVAILABLE: KINDLY INDICATE THE AFFECTED SIDE (LEFT/RIGHT HIP). PLEASE PROVIDE REASON WHY THE STEM WAS ALSO REVISED. WAS THE STEM LOOSED, MALPOSITION OR HAS ANY DEFICIENCY THAT CONTRIBUTED THE DISLOCATION EVENT. ARE THE PRODUCTS BEING RETURNED? IF YES, PLEASE IT TO THE ADDRESS BELOW." WHICH THEY REPLIED: "IT WAS HER RIGHT HIP, THERE WAS NO DEFICIENCY WITH THE STEM BUT IT WAS LOOSE. HE PRODUCTS ARE NOT BEING RETURNED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13044030 ↗
• InjuryAug 18, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (RIGHT HIP).

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

  MAUDE report 12337708 ↗
• InjuryFeb 1, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE BIPOLAR HEAD AND STEM WERE REMOVED DUE TO STEM SUBSIDENCE AND POSSIBLE INFECTION. LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE WAS ALSO REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, UNKNOWN SIDE OF THE HIP.

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

  MAUDE report 11260079 ↗
• InjuryJan 29, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND REVISION FOR PERI PROSTHETIC FRACTURE AROUND THE FEMORAL HIP STEM WAS PERFORMED. IT WAS ALSO REPORTED THAT THE STEM LOOSE. DOI: (B)(6) 2020: DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 11251731 ↗
• InjuryNov 23, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD PERI-PROSTHETIC FRACTURE IN FEMUR AROUND A BIPOLAR STEM. IT WAS ALSO REPORTED THAT THE STEM WAS LOOSE AT BONE TO IMPLANT INTERFACE. REVISED TO A RECLAIM BIPOLAR. DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 10889393 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BIPOLAR REVISION WAS DUE TO PERIPROSTHETIC FRACTURE SUSTAINED DURING A FALL. SUMMIT BASIC WAS REMOVED AND REPLACED WITH A RECLAIM BIPOLAR CONSTRUCT. DOI: (B)(6) 2018; DOR: (B)(6) 2020; LEFT HIP.

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

  MAUDE report 10252024 ↗
• InjuryFeb 14, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE HIP DISLOCATED AND COULD NOT BE REDUCED, SO THE PATIENT WAS OPENED AND THE SURGEON PULLED THE STEM OUT WITH LITTLE EFFORT. IT WAS INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9711176 ↗
• InjuryFeb 13, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A SUMMIT BASIC SZ 4 STEM, 43 MM BI-POLAR HEAD, AND. 28 + 1.5 HEAD WERE REMOVED. THE FEMORAL COMPONENT WAS LOOSE AT THE BONE TO IMPLANT INTERFACE DUE TO FRACTURE AFTER A PATIENT FALL. A NEW STEM, BI-POLAR HEAD, AND ARTICUL/EZE HEAD WERE IMPLANTED. NO ADDITIONAL INFORMATION. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT HIP.

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

  MAUDE report 9706939 ↗
• InjuryNov 25, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF THIGH PAIN. IT WAS ALSO INDICATED THAT THE STEM WAS FOUND TO BE LOOSE AT THE BONE TO IMPLANT INTERFACE AND WAS REPLACED WITH SUMMIT POROUS STEM WITH NEW HEAD AND LINER. DOI: (B)(6) 2018. DOR: (B)(6) 2019. RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9372635 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED DUE TO A FEMORAL NECK FRACTURE ON (B)(6) 2019. SHE BEGAN TO EXPERIENCE SOME REDNESS AND DRAINING FROM THE WOUND WITH IN DAYS AFTER THE SURGERY. THE SURGEON DECIDED TO DO AN I & D AND EXCHANGE IMPLANTS. THE SURGEON EXPLANTED ALL OF THE IMPLANTS AND DID A THOROUGH I&D. NEW IMPLANTS WERE IMPLANTED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Skin Irritation; Unspecified Infection

  MAUDE report 8902530 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAINFUL LEFT HIP HEMI. DOI: UNK, DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8604324 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED DUE TO A INTERTROCHANTERIC PERIPROSTHETIC FRACTURE. THE PATIENT'S PRIMARY DEPUY SUMMIT BASIC PRESS-FIT STEM AND BIPOLAR HEAD WERE REPLACED BY A LONG COMPETITOR'S RESTORATION STEM AND BIPOLAR HEAD. LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 8555979 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A LEFT HEMI HIP. THE PATIENT FELL AND FRACTURED HER FEMUR. THE SURGEON REMOVED HER PARTS AND FIXED THE FEMUR AND IMPLANTED NEW COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 8254174 ↗
• InjuryMay 14, 2018Loss of Osseointegration; Loss of Osseointegration

  DER STATES PATIENT WAS REVISED TO ADDRESS LOOSENING: BONE AND IMPLANT INTERFACE. IT WAS ALSO STATED PATIENT REVISED TO A TOTAL HIP FROM A UNIPOLAR. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7510857 ↗
• InjuryMar 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT FELL AND BROKE HER FEMUR, PERI PROSTHETIC FRACTURE. REVISED TO A LONGER STEM. DOI: (B)(6) 2018; DOR: (B)(6) 2018: LEFT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 7348080 ↗
• InjuryJul 21, 2017Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  UPDATE (B)(6) 2017: ADDITIONAL INFORMATION RECEIVED. THE SUMMIT BASIC STEM LOOSE. LOOSENING OCCURRED FROM BONE TO IMPLANT INTERFACE. THIS COMPLAINT WAS UPDATED ON A(B)(6) 2017.

  Patient problems: Pain

  MAUDE report 6731269 ↗