SUMMIT 1570-05-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295059691), received between Jan 8, 2018 and Sep 11, 2025 — classified as 14 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO THIGH PAIN, DUE TO A PERIPROSTHETIC STRESS FRACTURE APPROXIMATELY THIRTY MILLIMETERS SUPERIOR TO THE DISTAL TIP OF THE SUMMIT BASIC PRESS-FIT HIP HEMIARTHROPLASTY STEM. THE SUMMIT BASIC STEM WAS REMOVED AND REPLACED BY A LONGER ENDURANCE REVISION CEMENTED STEM, WHICH EXTENDED WELL BEYOND THE FRACTURE SITE DISTALLY. DOI - (B)(6) 2020. DOR - (B)(6) 2025. AFFECTED SIDE - LEFT HIP.

  Patient problems: Limb Fracture; Pain

  MAUDE report 23031455 ↗
• InjuryJun 6, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE DUE TO PERIPROSTHETIC FRACTURE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Limb Fracture

  MAUDE report 19478240 ↗
• InjuryMay 21, 2024Use of Device Problem; Osseointegration Problem; Use of Device Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD THIGH PAIN. LOOSE UNCEMENTED STEM WAS IN A VARUS POSITION AND UNDERSIZED. SURGEON REVISED ALL COMPONENTS. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19362490 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION AND REPLACED WITH A BALL OF CEMENT, THEN REIMPLEMENTED ON (B)(6) 2024. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18720901 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTEDLY FELL CAUSING A PERIPROSTHETIC FRACTURE. STEM AND MODULAR CATHCART HIP BALL WERE REMOVED AND REPLACED WITH REVISION CORAIL STEM AND NEW HIP BALL. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Limb Fracture

  MAUDE report 16145953 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIP FRACTURE AND PLACEMENT OF UNI-POLAR HEMI HIP IN 2015. SHE HAD GROIN PAIN AND RETURNED TODAY FOR REMOVAL OF HER HEMI HIP AND A THA WITH A CEMENTED SUMMIT. NO LOOSENING, BROKEN INSTRUMENTS, OR DELAYS. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15804041 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR FRACTURED FEMUR. SURGEON EXPLANTED THE SUMMIT BASIC STEM AND MONOPOLAR HEAD AND SLEEVE. IMPLANT A NEW CUP AND LIPPED LINER WITH A RECLAIM REVISION HIP STEM WITH A 36MM HEAD BALL. NO DELAY IN SURGERY. NO INJURY TO PATIENT. ORIGINAL DOS WAS 2017. LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 15649531 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR FEMUR FRACTURE. SURGEON EXPLANTED THE SUMMIT BASIC STEM AND UNIPOLAR HEAD AND SLEEVE. IMPLANT A NEW CUP AND LINER WITH A RECLAIM REVISION STEM AND 36MM HEAD BALL. NO DELAY IN SURGERY. NO INJURY TO PATIENT. PATIENT'S LEFT HIP. ORIGINAL DOS WAS IN 2017.

  Patient problems: Limb Fracture

  MAUDE report 15605651 ↗
• InjuryJul 23, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED PAINFUL HIP. THE STEM WAS LOOSENED AT THE BONE TO IMPLANT INTERFACE AND REVISED. THERE WERE NO REPORTED PRODUCT PROBLEMS WITH THE REVISED HEAD AND LINER. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10315716 ↗
• InjuryJun 21, 2018Osseointegration Problem; Osseointegration Problem

  DER STATES THAT THE PATIENT FELL AND DISLOCATED HER HIP. IT WAS ALSO INDICATED THAT THE PATIENT HAD PERIPROSTHETIC FRACTURE. THE STEM WAS ALSO LOOSE AT BONE TO IMPLANT INTERFACE. SURGEON IMPLANTED A NEW HEMI HIP AND CABLED THE FEMUR. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7624547 ↗
• InjuryMay 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT'S HIP WAS CONVERTED FROM HEMI TO A TOTAL DUE TO PAIN. SUMMIT BASIC STEM AND BIPOLAR HEAD WERE EXPLANTED, AND AN AML STEM, CUP, LINER AND HEAD WERE IMPLANTED. DOI: (B)(6) 2016; DOR: (B)(6) 2018; UNKNOWN HIP. NO SURGICAL DELAY.

  Patient problems: Not Applicable; Pain

  MAUDE report 7548660 ↗
• InjuryMay 15, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO INDICATED THAT THE SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH NEW TOTAL HIP. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP. NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration; Not Applicable; Unspecified Infection

  MAUDE report 7513739 ↗
• InjuryMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HEMI HIP. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT HIP. NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 7348219 ↗
• InjuryJan 8, 2018Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS FEMORAL STEM LOOSENING AT THE BONE TO CEMENT INTERFACE. CONVERSION FROM HEMI HIP TO TOTAL HIP REPLACEMENT. REPLACED WITH A SUMMIT POROCOAT. (B)(6) 2016; (B)(6) 2017; LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7171584 ↗