SUMMIT 1570-13-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295060222), received between Nov 22, 2017 and Sep 16, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presents with pain in her thigh post THA on the above listed date. There appears to be significant lysis around the femoral stem. This patient does not walk as she only transfers from a bed to a wheelchair. Stem is easily removed as the cement was only adhered to the stem proximally. Cement distal to the lytic activity was well fixed and left in place. Massive bone loss was noted both laterally and anteriorly. The liner was exchanged and a new stem and head were cemented with no delay nor patient harm. Cement pressurization was quite difficult with the missing bone but the new implants appeared to be well fixed and ROM was deemed appropriate by the surgeon. Distal centralizer was unable to be removed. It was reported that patient was revised due to femoral stem loosening at unknown interface. Cement manufacturer was unknown.DOI: on (b)(6) 2021,DOR: on (b)(6) 2026,Affected side: Left Hip.

  Patient problems: Bone Notching; Osteolysis; Pain

  MAUDE report 50790737 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50155373 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THEIR HIP. SURGEON REMOVED EXISTING IMPLANTS AND PUT IN A PROSTALAC HIP SPACER. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22215141 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO REPORTED SURGICAL DELAYS, PATIENT HARM, OR ALLEGATIONS.

  Patient problems: Limb Fracture

  MAUDE report 20464689 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION - SUPERFICIAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: 31 JAN 2024 (RIGHT HIP). TREATMENT: IRRIGATION AND DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 18694415 ↗
• InjurySep 16, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL STEM AT CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2003. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9072764 ↗
• InjurySep 16, 2019Loss of Osseointegration; Loss of Osseointegration

  PFS AND MEDICAL RECORDS RECEIVED. MEDICAL RECORDS SHOW THE PATIENT WAS REVISED AGAIN ON (B)(6) 2013 FOR A FAILED LINER. AFTER REVIEWING THE OPERATIVE NOTE IT SHOWED THE PATIENT HAD A BROKEN LIP OF THE LINER AND A MALPOSITIONED CUP. A ACETABULAR CUP AND UNKNOWN LINER ARE BEING REPORTED. (B)(4) IS A REOPEN OF (B)(4) DUE TO RECEIPT OF NEW INFORMATION. UPDATE 13 APR 2018. PINNACLE PFS, PPF AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES PAIN AND DIFFICULTY OF WALKING. PPF ALLEGES OF LOOSENING OF THE CUP. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, OPERATIVE REPORTED DATED (B)(6) 2013 THAT THERE IS A PLASTIC DEBRIS WHERE THE LIP OF THE CONSTRAINED LINER HAD BROKEN. IT WAS ALSO REPORTED THAT THE HEAD AND LOCKING RING WAS REMOVED. BUT THERE WAS NO REPORTED IN THE OPERATIVE REPORT THAT THE CUP WAS LOOSED.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Inadequate Osseointegration; No Code Available; Pain; Test Result

  MAUDE report 9070618 ↗
• InjuryApr 10, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  DER STATES THAT THE SURGEON TOLD NURSE THE REASON FOR REVISION WAS MECHANICAL FAILURE DUE TO FEMORAL STEM LOOSENING AT AN UNKNOWN INTERFACE. THE CEMENT MANUFACTURER IS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

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

  MAUDE report 7410936 ↗
• MalfunctionNov 22, 2017Defective Device; Defective Device

  DER STATES THAT THE NURSE WAS REMOVING IMPLANT FEMORAL STEM, THERE WERE 3 PLASTIC PINS ON IMPLANT FROM BLUE WRAPPER, PULLED IMPLANT FROM WRAPPER 2 PINS DETACHED THEMSELVES FROM IMPLANT.

  Patient problems: No Information

  MAUDE report 7053994 ↗