SOLUTION SYSTEM 1572-07-136Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295061502), received between May 12, 2021 and May 12, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2021Fracture; Osseointegration Problem; Fracture; Osseointegration Problem

  IT WAS REPORTED THAT THIS WAS A REVISION HIP TO REMOVE A BROKEN SOLUTION STEM, A COMPETITOR STEM WAS IMPLANTED AND PUT IN A PDM LINER IN A 54MM PINNACLE REVISION CUP. TREPHINES AND FLEXIBLE OSTEOTOMES WERE PROVIDED BY COMPETITOR TO GET THE STEM OUT. THE MODULAR COMPETITOR STEM WAS IMPLANTED AND THE 48MM PDM LINER WAS IMPACTED AFTER REMOVING THE PINNACLE POLY LINER AND 2 PERIPHERALS PINNACLE REVISION BONE SCREWS. THE PDM LINER WOULD NOT STAY SEATED WITH MULTIPLE TRIAL REDUCTIONS, THERE MAY HAVE BEEN TISSUE IN THE VIP TAPER. THE DECISION WAS MADE TO PUT IN ANOTHER PINNACLE POLY LINER. THE SURGEON IMPLANTED THE +1 32MM CERAMIC HEAD WHICH WAS THE ONLY OPTION AVAILABLE TO HIM, HE WAS UPSET THE COMPETITOR DIDN'T HAVE MORE SIZES FOR HIM. PATIENT EXPERIENCED LOOSENING OF THE STEM AT BONE TO IMPLANT INTERFACE AND SURGERY WAS EXTENDED FOR 5 HOURS DURING REVISION. THE BROKEN STEM WAS THE REASON FOR THE SECOND REVISION. THE ONLY IMPLANT THAT WAS NOT EXPLANTED WAS THE 54MM PINNACLE REVISION CUP. DOI: (B)(6) 2016. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11813199 ↗

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-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-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-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-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
• 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-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-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-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-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-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-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-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
• 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

…and 5 more.