SOLUTION SYSTEM 1572-01-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295061335), received between Oct 23, 2018 and Sep 18, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• InjurySep 18, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9081099 ↗
• InjuryOct 23, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PPF ALLEGES LOOSENING OF CUP AND ELEVATED METAL IONS.

  Patient problems: Test Result; Tissue Damage

  MAUDE report 7995756 ↗

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-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-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
• 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-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-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-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-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-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-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-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-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-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-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

…and 5 more.