SOLUTION SYSTEM 1572-02-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295061410), received between Apr 15, 2019 and May 5, 2023 — classified as 2 injuries.

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

• InjuryMay 5, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED PROGRESSIVE LEFT THIGH PAIN. BONE SCAN REVEALED THE FEMORAL COMPONENT WAS LOOSE. DOI- (B)(6) 2018. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16876444 ↗
• InjuryApr 15, 2019Fracture; Loss of Osseointegration; Osseointegration Problem; Fracture; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES STROKE, HEART ATTACK, COMPONENT FRACTURE, DISLOCATION, INFECTION, LOOSENING OF STEM AND ELEVATED METAL IONS. DOI: (B)(6) 2011, (HEAD, LINER & STEM) ; DOI: (B)(6) 2009, (CUP, SCREW); DOR: (B)(6) 2012, (RIGHT HIP).

  Patient problems: Cardiac Arrest; Inadequate Osseointegration; Infarction, Cerebral; No Code Available; Test Result; Unspecified Infection

  MAUDE report 8514051 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 5 more.