SUMMIT 1570-02-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295059431), received between Feb 13, 2018 and Sep 22, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Corroded” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PT. FELL AND FRACTURED THE PROXIMAL FEMUR. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AND CUP AT THE BONE TO IMPLANT INTERFACE. THE STEM WAS LOOSE BUT DURING THE CASE, THEY DISCOVERED THAT THE CUP WAS ALSO LOOSE. HE REVISED BOTH GOING TO A 48 CUP AND CORAIL REVISION STEM. EVERYTHING WAS STABLE FOLLOWING THE REVISION. DOI: (B)(6) 2021. DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Inadequate Osseointegration; Limb Fracture

  MAUDE report 12512907 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ADMITTED TO HOSPITAL WITH SUSPECTED C-DIFF, STOPPED TAKING ANTIBIOTICS, HIP UNSTABLE, HIP PROSTHESIS SUSPECTED TO BE INFECTED. ONCE EXPOSURE GAINED FRANK PUS EMERGED AND DECISION WAS MADE TO REMOVE ALL FEMORAL COMPONENTS.

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

  MAUDE report 11416375 ↗
• InjuryMar 13, 2020Corroded; Degraded; Corroded; Degraded

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP REPLACEMENT SECONDARY TO METAL-METAL DISEASE. PATIENT HAS ELEVATED METAL IONS AND A SMALL PSEUDOTUMOR. OPERATIVE NOTES STATED THAT A STANDARD ANTEROLATERAL APPROACH WAS MADE THROUGH THE PREVIOUS INCISION. THERE WAS NOTED TO BE SOME ABDUCTOR DISEASE BUT MOSTLY THE ABDUCTOR WAS INTACT. THE PSEUDOCAPSULE WAS EXCISED AND THIS WAS PSEUDOTUMOROUS. THERE WAS A SIGNIFICANT CORROSION NOTED WHEN THE HEAD WAS REMOVED FROM THE NECK. DOI: (B)(6) 2005. DOR: (B)(6) 2017. (RIGHT HIP). THE PATIENT HAS BILATERAL HIP IMPLANTS. PLEASE SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Test Result; Tissue Damage

  MAUDE report 9832068 ↗
• InjuryApr 10, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES METAL WEAR AND ELEVATED METAL IONS.

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

  MAUDE report 8500428 ↗
• InjuryFeb 13, 2018Corroded; Naturally Worn; Insufficient Device Problem Information; Corroded; Naturally Worn; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS ELEVATED ION LEVELS.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 7266071 ↗