SOLUTION SYSTEM 1571-84-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295061250), received between Oct 31, 2017 and Oct 31, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2022Fracture; Fracture

  LEGAL LETTER RECEIVED: OUR CLIENT WAS ADMITTED ON THE (B)(6) 2018 FOR ELECTIVE RIGHT HIP REVISION SURGERY. WE ATTACH IMPLANT TRACEABILITY STICKERS FOR YOUR ATTENTION. IN THE NEXT YEAR OF THIS SURGERY OUR CLIENT INFORMS US THAT HE SUFFERED EXCRUCIATING PAIN AS A RESULT THIS SURGERY AND LEARN IN OR AROUND EARLY (B)(6) 2019 THAT THE PROTHESIS THAT WAS IMPLANTED ON (B)(6) 2018 WAS IN FACT BROKEN. THIS RESULTED IN OUR CLIENT HAVING TO HAVE A RIGHT PROXIMAL FIBULAR REPLACEMENT DUE TO THE BROKEN PROTHESIS ON THE (B)(6) 2019. AS PREVIOUSLY STATED ABOVE PATIENT HAD TO HAVE A FURTHER OPERATION ON THE (B)(6) 2019 AS A RESULT OF THE BROKEN PROTHESIS. THE OPERATION THAT TOOK PLACE IN 2019 INVOLVED A DISSECTION DOWN TO THE BONE; THE BROKEN STEM OF IMPLANT IDENTIFIED; CABLES OF HOOK PLATE CUT AND PLATE REMOVED.

  Patient problems: Pain

  MAUDE report 15699307 ↗
• InjuryJul 1, 2020Fracture; Inadequacy of Device Shape and/or Size; Fracture; Inadequacy of Device Shape and/or Size

  REVISION HIP REPLACEMENT. PREVIOUSLY REVISED USING A SOLUTION STEM AT SMSA SEVERAL YEARS EARLIER. SOLUTION STEM HAD RECENTLY BROKEN MID SHAFT. REVIEW OF THE X-RAYS WITH THE SURGEON CONCLUDED THAT THE SOLUTION STEM HAD BEEN UNDERSIZED DUE TO A LARGE AMOUNT OF CEMENT NOT REMOVED FROM THE FEMORAL SHAFT FROM THE PRIMARY SURGERY. THE END POINT OF THE LARGE PIECE OF CEMENT MAY HAVE NOT ONLY CAUSED THE SOLUTION TO BE UNDERSIZED, BUT ALSO ACTED AS A STRESS RISER ON THE STEM. THE STEM BROKE JUST ABOVE THIS CEMENT.

  Patient problems: No Code Available; Pain

  MAUDE report 10221170 ↗
• InjuryNov 5, 2019Fracture; Fracture

  DATE: (B)(6) 2019. REVISION RIGHT TOTAL HIP FOR PERI PROSTHETIC FRACTURE. BROKEN SOLUTION STEM- SPONTANEOUS- PLEASE INVESTIGATE REASON FOR SAME. SURGEON REQUESTED INVESTIGATION.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9279109 ↗
• InjuryOct 31, 2017Fracture; Fracture

  THE PATIENT WAS REVISED TO ADDRESS FRACTURED OF PROXIMAL/METAPHYSEAL REGION OF THE STEM.

  Patient problems: No Information

  MAUDE report 6989836 ↗