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SOLUTION SYSTEM 1572-10-136Recalls & reported problems

Depuy Orthopaedics, Inc. · SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE LEFT 10 Inches 13.5mm · Class 2 · Implant

All models of SOLUTION SYSTEM (64)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295061649), received between Jan 10, 2017 and Oct 20, 2017 — classified as 2 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

Device problems

  • Loss of Osseointegration2
  • Fracture1
  • Osseointegration Problem1

Patient problems

  • No Information2
  • Ambulation or Postural Difficulties1
  • Bone Fracture(s)1
  • Discomfort1
  • Extraskeletal ossification1
  • Fatigue1
  • Inadequate Osseointegration1
  • Loss of Range of Motion1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 20, 2017Fracture; Loss of Osseointegration; Osseointegration Problem; Fracture; Loss of Osseointegration; Osseointegration Problem

    PFS ALLEGES PAIN, DIFFICULTY STANDING AND WALKING.

    Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Discomfort; Extraskeletal ossification; Fatigue; Inadequate Osseointegration; Loss of Range of Motion; Muscular Rigidity; No Information; Pain; Physical Asymmetry

    MAUDE report 6965806 ↗
  • InjuryJan 10, 2017Loss of Osseointegration; Loss of Osseointegration

    PATIENT WAS REVISED DUE TO DISLOCATION.

    Patient problems: No Information

    MAUDE report 6238800 ↗

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

…and 5 more.

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Sources and updates

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