SOLUTION SYSTEM 1572-08-136Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295061571), received between Nov 14, 2018 and Nov 20, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STICKER SHEETS RECEIVED VIA CD SHIPMENT. THERE ARE NO ALLEGATIONS REPORTED. STICKER SHEETS INDICATE THAT THE PATIENT HAD UNDERGONE A REVISION OF ACETABULAR CUP AND HEAD. HOWEVER, REASON FOR REVISION WAS NOT PROVIDED. IF/WHEN MORE INFORMATION IS RECEIVED, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. CUP WAS PREVIOUSLY REPORTED ON (B)(4). DOI: (B)(6) 2009; DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 9349277 ↗
• InjuryNov 14, 2018Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO A BREAK IN THE STEM.

  Patient problems: Pain

  MAUDE report 8069509 ↗

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-0575-2013 · Dec 3, 2012 · Terminated
  SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam s
• 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-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-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-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-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-0583-2013 · Dec 3, 2012 · Terminated
  SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa
• Z-0576-2013 · Dec 3, 2012 · Terminated
  SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam s
• 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-0574-2013 · Dec 3, 2012 · Terminated
  SOL SYS F 8 CALC 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 foam
• 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-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-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-0590-2013 · Dec 3, 2012 · Terminated
  SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foa

…and 5 more.