SOLUTION SYSTEM 1572-01-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295061359), received between Mar 14, 2018 and Feb 19, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN AND MULTIPLE DISLOCATIONS. UPDATE: PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2013 TO ADDRESS PAIN, ELEVATED CHROME AND COBALT LEVELS, METALLOSIS, AND EXTENSIVE SOFT TISSUE DAMAGE. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION. DOI: (B)(6) 2009; DOR: (B)(6) 2015; (LEFT HIP).

  Patient problems: No Code Available; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8349751 ↗
• InjuryMar 14, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED METAL IONS BEING RELEASED INTO PATIENT'S BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN THE THIGH AND GROIN. PATIENT HAS ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN THE HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE: 12/21/2012- PATIENT FACT SHEET RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. RECORDS ARE AVAILABLE ON THE L:\DRIVE IF NEEDED FOR FURTHER REVIEW. UPDATE REC'D 12/21/2012- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT PROVIDED. A CORRECT DOI HAS BEEN GIVEN. ORIGINAL LITIGATION MENTIONED ISSUES FROM METAL ON METAL; HOWEVER, THE STICKER SHEET INDICATES THAT THE PATIENT WAS ACTUALLY IMPLANTED WITH POLY. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 6/12/14. UPDATE 4/29/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THERE

  Patient problems: Discomfort; Distress; Inflammation; Injury; Pain; Unspecified Infection

  MAUDE report 7337284 ↗