SOLUTION SYSTEM 1572-01-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295061328), received between Jun 19, 2018 and Sep 30, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY DUE TO A BROKEN STEM. THE STEM FRACTURED, AND A NEW STEM WAS IMPLANTED. DOI: 2018; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9134065 ↗
• InjuryMar 29, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS THEN REVISED A SECOND TIME ON (B)(6) 2014 FOR PAIN, OSTEOLYSIS, METALLOSIS, MALPOSITIONED/LOOSE CUP, AND 2 BROKEN SCREWS AND 2 LOOSE SCREWS. LITIGATION ALSO ALLEGES ELEVATED METAL ION LEVELS. UPDATE IN ADDITION IN WHAT WAS PREVIOUSLY ALLEGED. PPF ALLEGES CONSTRAINED LINER, LOOSENING OF CUP, DISLOCATION AND ELEVATED METAL IONS. CUP, LINER, AND SCREWS WERE NON-DEPUY PRODUCTS. DOI: (B)(6) 2013; DOR: (B)(6) 2014, (RIGHT HIP).

  Patient problems: No Code Available; Osteolysis; Pain; Test Result; Tissue Damage

  MAUDE report 8464018 ↗
• InjuryJun 19, 2018Fracture; Fracture

  EVENT: AFTER PERFORMING THE HIP REVISION TO THE PATIENT, THE PATIENT RELATED THAT HE FELT WHEN THE BONE MADE A NOISE, IT WAS WHEN THE SPECIALIST PERFORMED AN X-RAY AND IT WAS VERIFIED THAT THE STEM WAS CRACKED. THE DAY AFTER HAVING TAKEN THE EXAM, THE PATIENT FELT ANOTHER NOISE IN HIS HIP AND IT WAS WHEN HE COMPLETELY FRACTURED THE ROD SOLUTION. PRODUCT CODE: (B)(4). LOT NOT INFORMED. PROCEDURE: HIP SURGERY. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION: PERFORM BONE OSTEOTOMY TO REMOVE THE PROSTHESIS. ACTION TAKEN FOR PROCEDURE: CHANGE OF SURGICAL APPROACH. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable

  MAUDE report 7613281 ↗

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