HIP PRESERVATION SYSTEM SIGNATURE SERIES HPS-HB12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20845854080525), received between Jun 4, 2019 and Sep 13, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• MalfunctionSep 13, 2019Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-HB12 DEVICE WAS BEING USED DURING A HIP ARTHROSCOPY WITH LABRAL REPAIR PROCEDURE ON (B)(6) 2019 WHEN THE BLACK BEARING NEAR THE HEAD OF THE BURN BEGAN TO FLAKE INSIDE THE HIP JOINT OF THE PATIENT. THE FLAKING MATERIAL WAS REMOVED WITH A SHAVER BLADE. THE DISINTEGRATION BEGAN WITHIN 2-5 MINUTES OF DEVICE USAGE. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION REQUIRED FOR THIS EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9039029 ↗
• MalfunctionJun 4, 2019Melted; Melted

  THE CONMED REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE, HPS-HB12, 5.5MM HPS PREBENT POLISHING BUR APPEARED TO HAVE MELTED AT THE HUB AND METAL SHAVINGS WERE SEEN IN THE SURGICAL SITE ON (B)(6) 2019 DURING A HIP ARTHROSCOPY. THE METAL SHAVINGS WERE WASHED OUT. THERE IS NO REPORTED PATIENT INJURY OR IMPACT. THERE WAS A SLIGHT DELAY TO GET ANOTHER HAND PIECE. THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666641 ↗