SUMMIT 1570-13-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295060246), received between Aug 15, 2017 and Jan 24, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF CEMENTED STEM AND HEAD. REPLACED WITH A LONGER CEMENTED STEM AND NEW HEAD. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18569901 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15951850 ↗
• InjuryJul 7, 2020Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PCF HAD NO ALLEGATIONS REPORTED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING, OSTEOLYSIS, PARTICLE DISEASE AND FAILURE OF A HIP REPLACEMENT. THE PATIENT PRESENTED WITH WORSENING PAIN AND WHAT APPEARED TO BE AN OSTEOLYTIC STRESS FRACTURE OF THE GREATER TROCHANTERIC REGION. REVISION NOTES STATED THAT A FEMUR WAS REMOVED WITHOUT DIFFICULTY AND LINER WAS REMOVED. THE STEM CAME OUT CLEAN WITHOUT ANY CEMENT ON IT. THERE WAS A LOT OF CEMENT DISTAL IN THE CANAL AND WAS REMOVED. OPERATIVE FINDINGS STATED THAT THERE WAS A CLEAR SYNOVIAL FLUID WITH PARTICLE INDUCED SYNOVITIS DIFFUSELY WITH BONE LOSS. THE TIP OF THE GREATER TROCHANTER WAS FRACTURED. THE FEMORAL STEM WAS GROSSLY LOOSE AND HAS SUBSIDED INTO THE CEMENT MANTLE WITH SEVERAL BROKEN CEMENT AREAS WITHIN THE JOINT. X-RAY IMAGES DEMONSTRATES A LEFT TOTAL HIP ARTHROPLASTY, A NON-DISPLACED GREATER TROCHANTER FRACTURE AND EVIDENCE OF PROSTHETIC LOOSENING. DOI: (B)(6) 2005; DOR: (B)(6) 2019 (LEFT HIP).

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

  MAUDE report 10240955 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PULMONARY EMBOLISM. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (RIGHT HIP).

  Patient problems: No Code Available; Pulmonary Embolism

  MAUDE report 10096508 ↗
• InjuryApr 26, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES PATIENT WAS REVISED TO ADDRESS SWELLING, DISCOMFORT, PAIN, DISLOCATION, LOOSENING AND INFECTION. METALLOSIS WAS ALSO NOTED. UPDATE: IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED THE PFS REPORTS SWELLING, AND INABILITY TO WALK. THE MEDICAL RECORDS FROM (B)(6) 2013 REPORT BILATERAL HIP FRACTURES. THE PATIENT WAS REVISED TO ADDRESS INFECTION 8 YEARS AFTER PRIMARY SURGERY. UPDATE PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2005; DOR: (B)(6) 2016, (LEFT HIP).

  Patient problems: Bone Fracture(s); Discomfort; No Code Available; Pain; Swelling; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8554900 ↗
• InjuryDec 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FOOT DROP.

  Patient problems: No Code Available

  MAUDE report 8132921 ↗
• InjuryMay 25, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD HIP REVISION FOR LOOSE, SUBSIDED CEMENTED FEMORAL STEM COMPONENT. NO INFECTION WAS PRESENT & A NEW REVISION STEM & HEAD BALL WERE INSERTED INTO PATIENT W/O INCIDENT.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7544216 ↗
• InjuryAug 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS PAIN, ELEVATED METAL ION LEVELS, AND BONE FRACTURE OF THE TROCHANTER. CLINICAL DER WAS ALSO RECEIVED ON 7/25/2014 STATING REVISION DUE TO OSTEOLYSIS. UPDATE JUL 17, 2017: LITIGATION RECEIVED. LITIGATION ALLEGES DEFECTIVE PINNACLE HIP HAD CAUSED DAMAGE TO PATIENT'S HIP JOINT AND BODY. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON AUG 7, 2017.

  Patient problems: Bone Fracture(s); Discomfort; Osteolysis; Pain; Weakness

  MAUDE report 6794691 ↗