HIP PRESERVATION SYSTEM SIGNATURE SERIES HPS-HB11Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20845854080518), received between Oct 7, 2019 and Jan 19, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-HB11, 5.5MM HPS PREBENT SPHERICAL BUR WAS BEING USED ON (B)(6) 2023 DURING A HIP ARTHROSCOPY LABRAL REPAIR AND FAI DEBRIDEMENT AND "DURING HIP ARTHROSCOPY 2 X HPS-HB11 FELL APART DURING OPERATION - HEAD FELL OFF AND THE BLACK PLASTIC SHEATH ALSO CAME OFF. THE ITEMS THEN NEEDED TO BE FISHED OUT OF THE HIP. MANUAL RETRIEVAL OF BUR AND SHEATH FROM JOINT¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE OF A DIFFERENT LOT NUMBER. THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545901 ↗
• MalfunctionDec 20, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-HB11, 5.5MM HPS PREBENT SPHERICAL BUR, WAS BEING USED DURING AN HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿THE BURR HEAD BROKE OFF IN THE PATIENT'S JOINT, AND THE DOCTOR WAS ABLE TO RETRIEVE IT." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED DELAY. A SECOND BUR, HPS-HB11, 5.5MM HPS PREBENT SPHERICAL BUR, WAS USED AS A CONCOMITANT DEVICE; HOWEVER, THE SURGEON FELT THE BLADE WAS NOT WORKING PROPERLY AND WAS CONCERNED THAT THE BURR HEAD WOULD COME APART AGAIN. THERE WAS NO REPORT OF THE ALTERNATE DEVICE HAVING ANY BREAKAGE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18362910 ↗
• MalfunctionDec 6, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, HPS-HB11, 5.5MM HPS PREBENT SPHERICAL BUR, WAS BEING USED DURING A HIP ARTHROSCOPY, CAM RESECTION ON (B)(6) 2023, AND ¿WE HAD 2 HPS-HB11 BURS MALFUNCTION IN THE SAME CASE THIS MORNING. THE FIRST BUR WAS ¿SKIPPING OR STALLING¿ WHILE THE FOOT PEDAL WAS COMPLETELY PRESSED. WE SWITCHED THE BUR OUT WITH ANOTHER ONE OF THE SAME LOT NUMBER AND IT BEGAN DOING THE SAME THING. THE SURGEON KEPT USING IT AND THE HEAD OF THE BUR BROKE OFF INSIDE THE HIP ON THE CAM RESECTION. HE WAS ABLE TO REMOVE IT QUICKLY WITH NO SIGNIFICANT DELAY.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. FURTHER ASSESSMENT CONFIRMED THAT THERE WAS NO INJURY, MEDICAL OR SURGICAL INTERVENTION FOR THE PATIENT OR USER, AND NO EXTENDED HOSPITAL STAY WAS REQUIRED FOR THE PATIENT. THE PATIENT IS REPORTEDLY DOING WELL. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277197 ↗
• MalfunctionDec 5, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-HB11, 5.5MM HPS PREBENT SPHERICAL BUR WAS BEING USED ON (B)(6) 2023 AND "WE HAD AN ISSUE TODAY WITH A NEW CONMED SURGEON. WE HAD 2 OF THE PRODUCTS ABOVE BREAK IN ONE CASE BACK-TO-BACK. WAS USING THE BURR IN ACCORDANCE TO HOW IT IS INTENDED TO BE USED AND HAD TO OPEN UP OTHER COMPANIES BURRS INSTEAD OF OURS TO FINISH THE CASE. BOTH WERE THE SAME LOT NUMBER¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT "THE DEVICE DID BREAK INTO THE SURGICAL FIELD AND ALL COMPONENTS WERE REMOVED FROM THE FIELD." THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265674 ↗
• MalfunctionOct 7, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT HPS-HB11 DEVICE WAS BEING USED DURING A HIP SURGERY ON (B)(6) 2019. AFTER 3-5 SECONDS THERE WAS A NOISE AND THEN THE DEVICE WAS STUCK. IT WAS REPORTER DURING ASSESSMENT QUESTIONING THAT "THERE WAS SOME PLASTIC ABRASION IN THE JOINT" THAT WAS REMOVED BY THE SURGEON. THERE WAS NO INJURY TO THE PATIENT OR USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9161238 ↗