SOLUTION SYSTEM 1571-46-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295061007), received between May 1, 2020 and May 1, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Corroded” (1 report).

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 1, 2020Corroded; Degraded; Corroded; Degraded

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED LEFT TOTAL HIP ARTHROPLASTY AND EVIDENCE OF CORROSION AT THE TAPER. OPERATIVE NOTE REPORTED DARKISH FLUID CONSISTENT WITH METAL WEAR DEBRIS. IT WAS CLEAR THAT THE PATIENT HAD GRADE 3 CORROSION AT THE TAPER WITHOUT SIGNIFICANT GRANULOMATOUS CHANGE. DOI: (B)(6) 2007 (HEAD & LINER); DOI: (B)(6) 2001 (STEM); DOR: (B)(6) 2019; (LEFT HIP, 2ND REVISION).

  Patient problems: Edema; No Code Available

  MAUDE report 10018370 ↗
• InjuryMay 1, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESSED INSTABILITY, INCREASING PAIN AND RECURRENT DISLOCATION. OPERATIVE NOTES INDICATED SOFT TISSUE IMPINGEMENT ANTERIORLY, THE NECK WAS SOMEWHAT ANTEVERTED AND WITH SIGNIFICANT INTERNAL ROTATION, FLEXION AND ADDUCTION OF THE HIP. DOI: (B)(6) 2001. DOR: (B)(6) 2007; (LEFT HIP, 1ST REVISION).

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 10017622 ↗