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SOLUTION SYSTEM 1257-65-000Recalls & reported problems

Depuy Orthopaedics, Inc. · SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 65mm · Class 2 · Implant

All models of SOLUTION SYSTEM (64)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295019947), received between Oct 26, 2017 and Apr 5, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Appropriate Device Problem Term/Code Not Available1
  • Loss of Osseointegration1

Patient problems

  • Unspecified Infection2
  • Discomfort1
  • Inadequate Osseointegration1
  • Inflammation1
  • No Code Available1
  • No Information1
  • Pain1
  • Scar Tissue1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 5, 2019Loss of Osseointegration; Loss of Osseointegration

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS INSTABILITY. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALLEGES THAT THE PATIENT FELT LIKE THERE WAS SCRAPING SENSATION IN HIS HIP, WALKING DIFFICULTY AND FALLING DOWN ON OCCASION. SURGEON RECOMMENDED REVISION SURGERY DUE TO LOOSE COMPONENT AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS CUP LOOSENING, METALLOSIS AND INSTABILITY. REVISION NOTES REPORTED THAT HIP WAS FOUND TO BE DISLOCATED, SYNOVIAL SCARRING, AND GROSSLY LOOSE CUP. IT WAS ALSO FOUND THAT THE STEM IS 20 DEGREES RETROVERTED. THE SLEEVE WAS LEFT IN PLACE AND STEM WAS ROTATED OVER 40 DEGREES TO PROVIDE APPROPRIATE ANTEVERSION THEN WAS RE-INSERTED. PATHOLOGY REPORT IS POSITIVE FOR ACUTE INFLAMMATION. LAB DATA SHOWS METAL ION LEVELS WERE ABOVE 7 PPB. DOI: (B)(6) 2007 - DOR: (B)(6) 2014, (RIGHT HIP).

    Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; No Code Available; Pain; Scar Tissue; Tissue Damage

    MAUDE report 8486599 ↗
  • InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ALLEGED INFECTION AFTER FIRST REVISION.

    Patient problems: Unspecified Infection

    MAUDE report 8164262 ↗
  • InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ALLEGED INFECTION AFTER FIRST REVISION.

    Patient problems: Unspecified Infection

    MAUDE report 8164251 ↗
  • InjuryOct 26, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE SURGEON HAS OBSERVED THAT THIS IMPLANT HAS UNSCREWED FROM A PERIPHERAL SCREW HOLE ON A PINNACLE REVISION CUP.

    Patient problems: No Information

    MAUDE report 6982623 ↗

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Sources and updates

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