SUMMIT 1570-13-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295060253), received between Sep 22, 2017 and Jul 9, 2025 — classified as 15 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT FAILED LEFT SUMMIT CEMENTED FEMORAL STEM WAS REMOVED WITH FEMORAL HEAD AND CEMENTRALIZER. CUP WAS LEFT IN PLACE WITH INSERTION OF NEW LINER. SUMMIT CEMENTED FEMORAL STEM WAS LOOSE AT CEMENT TO IMPLANT INTERFACE. CEMENT FROM COMPETITOR BRAND WAS USED. DOI: (B)(6) 2023, DOR: (B)(6) 2025 , AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22464248 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENTS RECEIVED FOR INFECTION - DEEP. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: PROBABLY. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: (B)(6) 2024. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REVISION.

  Patient problems: Adhesion(s); Impaired Healing; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20057063 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024, DATE REVISION: (B)(6) 2024, DATE OF EVENT: (B)(6) 2024, (LEFT HIP). TREATMENT: REVISION; PRODUCTS REVISED UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19537816 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A GROSSLY INFECTED HIP. EXPLANTED ALL COMPONENTS. I&D HIP AND IMPLANTED A PROSTALAC STEM AND CUP WITH ANTIBIOTICS. NO OTHER INFORMATION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18764460 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF HIP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18436050 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION DATE OF IMPLANTATION: (B)(6) 2013. DATE OF REVISION #1: (B)(6) 2013. DATE OF REVISION #2:(B)(6) 2015. DATE OF REVISION #3: (B)(6) 2021. DATE OF REVISION #4: (B)(6) 2021. DATE OF REVISION#5: (B)(6) 2022. (LEFT HIP).

  Patient problems: Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15520643 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL PERIPROSTHETIC FRACTURE (INTRAOPERATIVE). EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. LEFT HIP. TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Limb Fracture

  MAUDE report 15043297 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS NOW BEEN REVISED TO ADDRESS A CONFIRMED INFECTION WITH EXPLANTATION OF ALL PRODUCTS. THIS INCLUDING THE USE OF AN OPENING FEMORAL OSTEOTOMY TO FACILITATE REMOVAL OF THE FEMORAL STEM. AN ANTIBIOTIC SPACER WAS RE-IMPLANTED TO ADDRESS THE INFECTION. ALL DEVICES ARE CONSIDERED REPORTABLE, GIVEN THAT IT IS NOT POSSIBLE TO RULE-OUT THEIR POSSIBLE CONTRIBUTION, GIVEN THAT THEY PRESENT A SAFE HARBOR FOR INFECTIOUS MICROORGANISMS TO TAKE HOLD.

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

  MAUDE report 11855024 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS INFECTED, SURGEON DID A WASHOUT AND REPLACED ALL IMPLANTS.

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

  MAUDE report 11780209 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT HIP IRRIGATION AND DEBRIDEMENT DUE TO CONTINUED WOUND DRAINAGE FROM STAGE ONE REVISION FOR TREATMENT OF DEEP INFECTION. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF REVISION: (B)(6) 2020, (RIGHT HIP).

  Patient problems: Impaired Healing; No Code Available; Thrombosis; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 10176290 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019; DATE OF EVENT: (B)(6) 2019, (LEFT HIP).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 8875304 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DVTS BILATERALLY: VASCULAR - DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DOI: (B)(6) 2019; DOR: (B)(6) 2019 ,(PELVIC FRACTURE: CUP, LINER, AND HEAD REVISED); DOE: (B)(6) 2019, (RIGHT HIP). DEPUY HIP COMPONENTS PRESENT AT THE TIME OF THE AE: CATALOG ID: 101185000, LOT: 348034, DESCRIPTION: PROTRUSIO CAGE 48MM X 45MM RT; CATALOG ID: 122132048, LOT: J19U80, DESCRIPTION: PINNACLE ALTRX POLYETHYLENE ACETABULAR LINER NEUTRAL 32MM ID 48MM OD; CATALOG ID: 136521000, LOT: D18122792, DESCRIPTION: ARTICUL/EZE HEAD COCR 32MM +1; CATALOG ID: 545032500, LOT: 8719593, DESCRIPTION: DEPUY CMW 2 GENTAMICIN BONE CEMENT ; CATALOG ID: 545032500, LOT: 8939042, DESCRIPTION: DEPUY CMW 2 GENTAMICIN BONE CEMENT ; CATALOG ID: 3322020, LOT: 8885300, DESCRIPTION: SMART SET BONE CEMENT 20G; CATALOG ID: 101140020, LOT: J30C19, DESCRIPTION: SELF TAPPING SCREW 20MM; CATALOG ID: 101140020, LOT: J30C19, DESCRIPTION: SELF TAPPING SCREW 20MM; CATALOG ID: 101140015, LOT: 371070, DESCRIPTION: ROOF PILE SCREW 15MM; CATALOG ID: 101140025, LOT: HD7680, DESCRIPTION: ROOF PILE SCREW 25MM;

  Patient problems: Thrombosis

  MAUDE report 8682610 ↗
• InjurySep 6, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FAILED LEFT HIP. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Pain; Test Result

  MAUDE report 7850099 ↗
• InjuryOct 20, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AT THE CEMENT TO IMPLANT INTERFACE, COMPETITOR CEMENT WAS USED. IT WAS INDICATED THAT THE STEM AND CEMENT WERE REMOVED AND S-ROM STEM WAS IMPLANTED.

  Patient problems: Joint Dislocation; No Information

  MAUDE report 6965424 ↗
• InjurySep 22, 2017Loss of or Failure to Bond; Migration or Expulsion of Device; Loss of or Failure to Bond; Migration or Expulsion of Device

  CLINICAL DER RECEIVED. AE RECEIVED FOR MIGRATION / LOOSENING OF STEM (LOOSENING INTERFACE NOT PROVIDED). CEMENT MANUFACTURER WAS UNKNOWN. EVENT MEETS THE DEFINITION OF SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. EVENT IS AWAITING REVISION. UPDATE AUG 23, 2017: ADDITIONAL INFORMATION RECEIVED. UPDATE: REVISION DUE TO LOOSENING OF THE STEM. DEPUY STEM, HEAD AND LINER WERE REVISED ON (B)(6) 2017. ALERT DATE FOR THIS INFORMATION IS 8-23-2017. THIS COMPLAINT WAS UPDATED ON AUG 24, 2017.

  Patient problems: No Information

  MAUDE report 6887135 ↗