SUMMIT 1570-03-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295059530), received between May 25, 2018 and Dec 22, 2025 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STEM WAS LOOSE AND CAME OUT AFTER REMOVING THE HEAD. IT WAS STATED THAT THE STEM WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23864747 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE AROUND A CEMENTED HIP STEM. LOT NUMBER OF HEAD NOT RECORDED IN HOSPITAL RECORD AND NO VISIBLE ON IMPLANT. DOI: UNKNOWN, DOR: (B)(6), AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 16761182 ↗
• InjuryNov 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED FOR PAIN. THERE WAS A LOOSENING REPORTED AT CEMENT TO IMPLANT INTERFACE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 15788164 ↗
• InjurySep 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LOOSENING OF THE STEM AT AN UNKNOWN INTERFACE. COMPETITOR BONE CEMENT WAS USED. DOI: (B)(6) 2017, DOR: (B)(6), 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 12487312 ↗
• InjuryDec 4, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PFS, PPF, IMPLANT RECORD AND MEDICAL RECORDS RECEIVED. PFS HAS NO ALLEGATION PPF ALLEGES INFECTION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT HIP ARTHROPLASTY. OPERATIVE NOTES REPORTED OF SOME SUPERFICIAL FLUID AND NECROTIC DEBRIS. THE CUP CAME OUT WITHOUT ANY DIFFICULTY AND THE STEM WAS GROSSLY LOOSE. DOI: (B)(6) 2015 (HEAD & LINER) DOI: (B)(6) 2004 (STEM, CUP, SCREWS, CENTRALIZER, CEMENT, ELIMINATOR) DOR: (B)(6) 2016 RIGHT HIP 7TH REVISION PLEASE SEE PC-(B)(4) RIGHT HIP 1ST REVISION. PC-(B)(4) RIGHT HIP 2ND REVISION. PC-(B)(4) RIGHT HIP 3RD REVISION. PC-(B)(4) RIGHT HIP 4TH REVISION. PC-(B)(4) RIGHT HIP 5TH REVISION. PC-(B)(4) RIGHT HIP 6TH REVISION.

  Patient problems: Inadequate Osseointegration; Necrosis; No Code Available; Unspecified Infection

  MAUDE report 9410801 ↗
• InjuryNov 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINT DESCRIPTION: PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED FOR DISLOCATION AND INSTABILITY. UPDATE 17 AUG 2018 COM-(B)(4) HAS BEEN RE-OPENED UNDER PC-(B)(4) DUE TO RECEIPT OF PPF, IMPLANT RECORDS AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, CONSTRAINED LINER, BONE FRACTURE, ABDUCTOR MUSCLE REPAIR, INFECTION, AND LOOSENING OF STEM. DOI: (B)(6) 2013 (LINER AND HEAD) - DOR: (B)(6) 2014 (RIGHT HIP). DOI: (B)(6) 2004 (CEMENT, SCREWS, CEMENT RESTRICTOR, STEM CENTRALIZER, APEX HOLE ELIMINATOR, STEM, AND CUP).

  Patient problems: Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Tissue Damage; Unspecified Infection

  MAUDE report 9321135 ↗
• InjuryApr 2, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PPF ALLEGES INFECTION AND LOOSENING OF STEM. AFTER REVIEW OF THE MEDICAL RECORDS, REVISION NOTES NOTED PAIN, STEM LOOSENING AND MISPOSITIONED CUP. IT WAS ALSO STATED THE FEMORAL COMPONENT WAS REMOVED ALONG WITH THE MAJORITY OF CEMENT MANTLE, COMPETITOR CEMENT WAS USED. THE PATIENT WBC WAS ABOVE 11 MCL. THERE WERE NO MENTION OF DISLOCATION, COMPONENT FRACTURE AND CUP LOOSENING IN THE REVISION NOTES. DOI AND DOR: UNKNOWN; AFFECTED SIDE UNKNOWN.

  Patient problems: No Code Available; Pain

  MAUDE report 8473094 ↗
• MalfunctionJan 24, 2019Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE SURGEON REQUESTED THE 3 STANDARD SUMMIT CEMENTED STEM. WHEN NURSE WAS OPENING THE BOX, THE PLASTIC ENCASEMENT THAT HOLDS THE IMPLANT WAS CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8273230 ↗
• InjuryMay 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT HAS SOME TYPE OF SEIZURE DISORDER. HAD A FALL AFTER HEMIARTHROPLASTY (B)(6) 2018. SURGEON CHANGED HEAD SHELL AND FIXED A BONE FRACTURE WITH PLATES, SCREWS AND CABLES. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 7544901 ↗