Alexis ® Orthopaedic Protector HR005Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607915123192), received between Mar 7, 2018 and Mar 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Torn Material” (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.

• MalfunctionMar 7, 2018Torn Material; Torn Material

  PROCEDURE PERFORMED: "TOTAL HIP ARTHROPLASTY." EVENT DESCRIPTION: "[SURGEON] FROM (B)(6) HOSPITAL WAS DOING A TOTAL HIP ARTHROPLASTY (POSTERIOR APPROACH) DURING THE END OF THE CASE WHEN HE WAS PUTTING IN THE FEMORAL IMPLANT, IT GOT CAUGHT ON THE ALEXIS UNBEKNOWNST TO HIM AN THE STAFF. WHEN [SURGEON] TRIED TO REMOVE THE ALEXIS AFTER THE IMPLANTS WERE PLACED, HE NOTICED THAT THE FEMORAL IMPLANT WAS CAUGHT ON THE ALEXIS. THIS REQUIRED [SURGEON] TO HAVE TO CUT THE ALEXIS FROM THE IMPLANT AND THEN REMOVE THE IMPLANT TO REMOVE THE TORN PIECE OF ALEXIS THAT WAS CAUGHT IN IT. HAVING THE ALEXIS CAUGHT IN THE IMPLANT MADE HIM WEARY OF THE DEVICE BECAUSE HE HADN'T NOTICED IT, THERE COULD'VE BEEN A PIECE OF THE ALEXIS LEFT IN THR PATIENT." TYPE OF INTERVENTION: "THIS REQUIRED [SURGEON] TO HAVE TO CUT THE ALEXIS FROM THE IMPLANT AND THEN REMOVE THE IMPLANT TO REMOVE THE TORN PIECE OF ALEXIS THAT WAS CAUGHT IN IT." PATIENT STATUS: "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7322571 ↗