SOLUTION SYSTEM 1572-01-136Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295061342), received between Jan 21, 2019 and Sep 9, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN AND DISCOMFORT. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES INFECTION. DOI: (B)(6) 2009, DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: Discomfort; No Code Available; Pain; Unspecified Infection

  MAUDE report 8977378 ↗
• InjuryAug 20, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD A LOOSE FEMORAL STEM. SURGEON REVISED THE STEM AND CHANGED THE LINER. DOI: (B)(6) 2008; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8910698 ↗
• InjuryMar 21, 2019Biocompatibility; Biocompatibility

  PPF ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Loss of Range of Motion; Pain; Test Result

  MAUDE report 8439461 ↗
• InjuryJan 21, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF, IMPLANT RECORDS AND STICKER SHEETS RECEIVED. PPF ALLEGED LOOSENING OF STEM AFTER FIRST REVISION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8264668 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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.