SOLUTION SYSTEM 1572-02-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295061427), received between May 9, 2019 and Apr 25, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

20 other recalls cover devices cleared under the same FDA submission (K060581); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19182742 ↗
• InjuryAug 30, 2022Fracture; Fracture

  SOLUTION STEM BROKE DOI: UNK. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 15321023 ↗
• InjuryMay 9, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN AND DIFFICULTY AMBULATING. UPDATE: IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES FRACTURE(BONE) AFTER 1ST REVISION. DOI: (B)(6) 2011; DOR: (B)(6) 2012; (RIGHT HIP).

  Patient problems: No Code Available; Pain; Unspecified Infection

  MAUDE report 8594850 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060581. One submission often covers many models, so check the product and lot details in each record.

• Z-0591-2013 · Dec 3, 2012 · Terminated
  SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam
• Z-0585-2013 · Dec 3, 2012 · Terminated
  SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa
• Z-0577-2013 · Dec 3, 2012 · Terminated
  SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam s
• Z-0578-2013 · Dec 3, 2012 · Terminated
  SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam s
• Z-0588-2013 · Dec 3, 2012 · Terminated
  SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa
• Z-0589-2013 · Dec 3, 2012 · Terminated
  SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam
• Z-0586-2013 · Dec 3, 2012 · Terminated
  SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa
• Z-0580-2013 · Dec 3, 2012 · Terminated
  SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa
• Z-0592-2013 · Dec 3, 2012 · Terminated
  SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa
• Z-0579-2013 · Dec 3, 2012 · Terminated
  SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa
• Z-0582-2013 · Dec 3, 2012 · Terminated
  SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam
• Z-0581-2013 · Dec 3, 2012 · Terminated
  SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa
• Z-0573-2013 · Dec 3, 2012 · Terminated
  SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sle
• Z-0587-2013 · Dec 3, 2012 · Terminated
  SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa
• Z-0584-2013 · Dec 3, 2012 · Terminated
  SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam

…and 5 more.