SUMMIT 1570-03-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295059547), received between Jul 27, 2017 and Mar 30, 2026 — classified as 15 injuries, 1 malfunction.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STEM WAS LOOSE. THE REP DO NOT HAVE ANY INFO ON WHAT CEMENT WAS USED BUT STEM CAME OUT WITH STEM FULLY COATED IN CEMENT EXCEPT THE TIP. LOOSENING INTERFACE: UNKNOWN . AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728507 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BIPOLAR REMOVED BECAUSE OF INFECTION. AFFECTED SIDE-LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23716154 ↗
• InjuryJul 3, 2025Migration; Migration

  IT WAS REPORTED THAT THE STEM SUBSIDED INTO VALGUS. CONVERTED THE CUP TO DUAL MOBILITY. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22397095 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STAGE 2 REVISION DUE TO INFECTION. THERE WAS NO ISSUE WITH PRODUCTS AND NO TIME WASTED DUE TO PRODUCTS. DOI: (B)(6) 2024, DOR: UNKNOWN, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22122132 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT HEMI-ARTHROPLASTY REVISION TO PROSTALAC BECAUSE OF INFECTION. NO ADVERSE EFFECTS OR SURGICAL DELAYS. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21576731 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HIP REVISION OF CEMENTED BIPOLAR CONSTRUCT DUE TO INSTABILITY AND DISLOCATION. STEM WAS REMOVED AND A NEW STEM WAS CEMENTED IN PLACE. THIS WAS IMPLANTED WITH A COMPETITORS DUAL MOBILITY CUP CONSTRUCT. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 11237880 ↗
• InjuryJan 2, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT AND BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, (LEFT HIP).

  Patient problems: No Code Available

  MAUDE report 9540960 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS LEFT HIP WAS REVISED DUE TO INFECTION AND AN ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9538309 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9343013 ↗
• InjuryMay 13, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS ALSO REMOVAL OF IMPLANTS, WASH OUT AND RE-IMPLANTATION. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8604803 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION, METALLOSIS, ELEVATED METAL IONS AND METAL WEAR. DOI: (B)(6) 2007, DOR: (B)(6) 2007, (LEFT HIP). THIS PC IS FOR THE FIRST REVISION OF THE LEFT HIP.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8428863 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AND ELEVATED METAL IONS AFTER FIRST REVISION.

  Patient problems: Test Result; Unspecified Infection

  MAUDE report 8196225 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: CLINICAL DER STATES THAT PATIENT EXPERIENCED FEMORAL LOOSENING, NOTED TO BE RELATED TO AN INTRAOP CEMENT MANTLE FRACTURE. EVENT DOES NOT MEET THE DEFINITION OF SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. / / INVESTIGATION METHOD: MEDICAL RECORDS REVIEWED ((B)(6) 2017) - (CH) FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED.

  Patient problems: Bone Fracture(s)

  MAUDE report 7298863 ↗
• InjuryJan 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED HIP AND PAIN. DOI: UNKNOWN; DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7215011 ↗
• MalfunctionDec 20, 2017Device Disinfection Or Sterilization Issue; Device Disinfection Or Sterilization Issue

  IT WAS STATED THAT STERILIZATION WAS COMPROMISED DUE TO HAIR BEING FOUND ON IMPLANTS. DID NOT NOTICE WHICH PACKAGE IT CAME FROM BECAUSE IMPLANTS HAD BEEN ASSEMBLED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7135209 ↗
• InjuryJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS THE REMOVAL OF PROSTALAC DUE TO INFECTION AND FEMUR FRACTURE. IT WAS REPLACED ALL WITH TOTAL PROSTALAC.

  Patient problems: Bone Fracture(s)

  MAUDE report 6746821 ↗