NA 02.221.152Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982276520), received between Aug 30, 2023 and Aug 30, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE, WHILE PERFORMING A PERIPROSTHETIC FRACTURE ORIF AND AFTER PLACING TWO CABLES, THE SURGEON NOTICED THAT TWO OF THE CABLES WERE LOOSER THAN ANTICIPATED. THEY DECIDED THAT IT WAS MORE DUE TO TECHNIQUE AND CUT THE CABLES OUT, AND PLACED TWO NEW ONES TO REDUCE THE FRACTURE. SALES REP LET THE SURGEON KNOW THE MINIMUM FIXATION RECOMMENDATIONS OF TWO CABLES PROXIMALLY IN THIS TYPE OF FRACTURE. THEY CHOSE TO ONLY USE ONE CABLE AND ACCEPTED IT. WHILE USING THE PPFX PROXIMAL FEMUR SYSTEM, THE SURGEON SAID THE PLATE DID NOT PROPERLY FIT THE PATIENT'S CONTOUR AND THE DISTAL SPANNING PLATE WAS NOT PROPERLY DESIGNED TO FIT THE DISTAL FEMUR CONDYLE. THE PROXIMAL FEMUR PPFX WAS BENT DISTALLY AND THE SURGERY WAS SUCCESSFULLY COMPLETED. DURING THE SURGERY THEY ALSO NEEDED A 70MM 5MM VA LOCKING, HOWEVER THE SET WAS ONLY SENT WITH SCREWS UP TO 60MM WHICH SURGEON HAD TO USE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TEN (10) MINUTES. THIS REPORT IS FOR ONE (1) 3.5MM VA PPFX DSTL FEMUR SPAN ATTCHMT PL/4H LNG/RIGHT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17655586 ↗