SOLUTION SYSTEM 1572-11-136Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295061717), received between Dec 1, 2017 and Feb 17, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC OF THEIR COMPETITOR HEMI HIP PROSTHESIS. THE SURGEON REMOVED THE INDWELLING HIP AND REPLACED IT WITH A 10¿ BOWED SOLUTION STEM AND A NEW HEMI HEAD/TAPER SPACER ON (B)(6) 2022. A FEW DAYS AFTER THIS SURGERY, THE PATIENT'S HIP DISLOCATED. THE SURGEON DETERMINED THAT THE STEM ROTATED AND NEEDED TO BE REPLACE WITH A LARGER DIAMETER STEM. THIS NEW PROCEDURE HAPPENED ON (B)(6) 2022. THE STEM, HEAD AND TAPER SPACER WERE ALL REPLACED. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13548474 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENTS WAS REVISED TO ADDRESS RIGHT HIP INFECTION. ALL COMPONENTS WERE REMOVED AND A PROSTALAC IMPLANT WAS IMPLANTED. RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8574544 ↗
• InjuryMay 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND MEDICAL RECORDS RECEIVED. PLAINTIFF PROFILE FORM ALLEGES LOOSENING OF CUP, INFECTION, LOOSENING OF STEM. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS DETERMINED THAT THE PATIENT HAD A TWO STAGE REVISION DUE TO INFECTION FROM THE PREVIOUS UNKNOWN MANUFACTURER HIP IMPLANT WITH THE FIRST STAGE REVISION TO A TOTAL DEPUY HIP. REVISION NOTES REPORTED THAT THE PATIENT UNDERWENT THE SECOND STAGE REVISION, AND ALL THE FEMORAL AND ACETABULAR COMPONENTS WERE REVISED TO A COMPETITOR HIP. THERE WERE NO INDICATIONS OF LOOSENING AND INFECTION FOR THE REVISED DEPUY IMPLANTS. DOI: (B)(6) 2007; DOR: (B)(6) 2013; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Not Applicable; Unspecified Infection

  MAUDE report 7544457 ↗
• InjuryDec 1, 2017Break; Break

  PATIENTS 13.5X10¿ SOLUTION STEM (IMPLANTED (B)(6) 2015)BROKE. IT WAS REPLACED WITH A 10¿X21MM SOLUTION STEM. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION:PATIENT REQUIRED REVISION HIP SURGERY. ACTION TAKEN FOR PROCEDURE:STEM WAS REMOVED AND REPLACED WITH ANOTHER. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7074516 ↗

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