SOLUTION SYSTEM 1571-53-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295061069), received between Apr 5, 2018 and Jun 26, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (5 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 18, 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.

• InjuryJun 26, 2019Fracture; Fracture

  SURGEON REPORTED AE TO BFARM: PATIENT CAME TO HOSPITAL WITH STRONG PAIN. NO TRAUMA. X-RAY SHOWED A STEM FRACTURE. REVISION WITH CHANGE OF INLAY AND STEM WITH FRACTURE-OSTEOSYNTHESIS ON (B)(6) 2019.

  Patient problems: Hip Fracture; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8736985 ↗
• InjuryMay 29, 2019Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE AFFECTED SIDE WAS THE RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8649533 ↗
• InjuryJun 19, 2018Fracture; Fracture

  IMPLANT BREAKAGE. THE PATIENT ACCEPTED LEFT THA ON (B)(6) 2013. NO ANOMALY WAS OBSERVED. THE PATIENT FELT PAIN AND RETURNED HOSPITAL ON (B)(6) 2018. X-RAY REPORT INDICATED SOLUTION STEM BROKE. REVISION SURGERY WILL BE DONE. NOW PATIENT IS AT HOSPITAL FOR MONITORING.

  Patient problems: Pain

  MAUDE report 7615639 ↗
• InjuryMay 1, 2018Fracture; Fracture

  IMPLANT BREAKAGE. THE PATIENT NAMED (B)(6) IS FEMALE, (B)(6) YEARS OLD AND (B)(6), ACCEPTED THA ON (B)(6) 2012. NO ANOMALIES WERE OCCURRED IN PROCEDURE. THE HIP OF PATIENT FELT PAIN AND RETURNED HOSPITAL ON (B)(6) 2018. X-RAY REPORT INDICATED IMPLANT BROKE. THE BROKEN DEVICE WILL BE EXCHANGED IN REVISION SURGERY ON (B)(6) 2018. THE PATIENT IS UNDER MONITORING AT HOSPITAL. DOI: (B)(6) 2012; DOR: PLANNED ON (B)(6) 2018; UNKNOWN HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7475126 ↗
• InjuryApr 5, 2018Fracture; Fracture

  THE SOLUTION FEMUR STEM WAS FOUND BROKEN AFTER IMPLANTED 2 YEARS IN PATIENT BODY WITHOUT ANY FALL OR ACCIDENT. PATIENT CONSEQUENCE? YES. PATIENT CONSEQUENCE DESCRIPTION:SOLUTION STEM BROKEN AFTER IMPLANTED FOR 2 YEARS IN PATIENT BODY WITHOUT ANY FALL OR ACCIDENT AFTER THE SURGERY. ACTION TAKEN FOR PROCEDURE:REMOVE THE BROKEN STEM AND IMPLANT A NEW FEMORAL STEM IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable

  MAUDE report 7398968 ↗