PHYSICA Instrument Set Fem. Trial/PS Box Guide Ins./Extr.Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390103572), received between Mar 12, 2026 and Mar 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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 18, 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.

• MalfunctionMar 23, 2026Mechanical Problem

  DURING THE USE OF THE FEMORAL TRIAL HOLDER / PS BOX GUIDE (9065.88.140, LOT 24BG00N) IN A KNEE SURGERY PERFORMED ON (B)(6) 2026, AN ISSUE OCCURRED WHERE THE LOCK FAILED TO REMAIN SECURED AND LOOSENED AFTER HAMMERING. THE SURGERY WAS DELAYED BY APPROXIMATELY 20-30 MINUTES. EVENT HAPPENED IN SOUTH KOREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663388 ↗
• MalfunctionMar 12, 2026Break

  DURING A KNEE SURGERY PERFORMED IN KOREA, THE FEMORAL TRIAL HOLDER / PS BOX GUIDE (9065.88.140 LOT. 21BG04L) WAS DAMAGED DURING THE HAMMERING PROCESS WHILE IN USE. THE BROKEN FRAGMENTS WERE RETRIEVED FROM THE SURGICAL SITE. THE HANDLE FUNCTIONED NORMALLY, AND THE SURGERY WAS COMPLETED USING AN ALTERNATIVE INSTRUMENT. SURGERY WAS PROLONGED 30-40 MINUTES. EVEN HAS OCCURRED IN SOUTH KOREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579795 ↗
• MalfunctionMar 12, 2026Mechanical Problem

  DURING A KNEE SURGERY PERFORMED IN KOREA ON (B)(6) 2026, AN ISSUE OCCURRED WHILE USING THE FEMORAL TRIAL HOLDER/PS BOX GUIDE (PRODUCT CODE 9065.88.140, LOT 25BG05R) IN WHICH THE LOCK MECHANISM COULD NOT BE RELEASED AFTER HAMMERING. THE SITUATION WAS PROMPTLY ADDRESSED BY USING FUNCTIONING INSTRUMENTS, ALLOWING THE SURGERY TO PROCEED SAFELY. THE SURGERY WAS PROLONGED BY 30/40 MINUTES. THIS EVENT HAPPENED IN SOUTH KOREA.

  Patient problems: Insufficient Information

  MAUDE report 24579574 ↗