HIP PRESERVATION SYSTEM SIGNATURE SERIES HPS-H001Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20845854020682), received between Jun 22, 2018 and Jul 31, 2018 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5 MM X 19 CM HPS SPHERICAL BUR, BROKE DURING A HIP ARTHROSCOPY PROCEDURE, DATE UNKNOWN. IT WAS REPORTED THAT NO COMPONENT OF THE DEVICE FELL INTO THE SURGICAL SITE; THEREFORE, THERE WERE NO FRAGMENTS TO RETRIEVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE REPORTER HAS STATED THAT NEITHER THE PATIENT OR USER WERE INJURED DURING THIS EVENT. THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION AND THERE WAS NO EXTENDED HOSPITAL STAY REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL OF INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7735943 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5 MM X 19 CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING SURGERY. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, THAT INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 7628394 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5 MM X 19 CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING SURGERY. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, THAT INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 7628393 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5MM X 19CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING SURGERY. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, THAT INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 7628391 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5MM X 19CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING SURGERY. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, THAT INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 7628390 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5MM X 19CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING SURGERY. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, THAT INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 7628388 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5MM X 19CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING SURGERY. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, THAT INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 7628387 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5 MM X 19 CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING SURGERY. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, THAT INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 7628386 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5MM X 19CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING SURGERY. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, THAT INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 7628381 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5MM X 19CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING SURGERY. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, THAT INFORMATION HAS NOT BEEN MADE AVAILABLE. 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 7628380 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE HPS-H001, 4.5MM X 19CM HPS SPHERICAL BUR, DEVICE BROKEN MID-SHAFT DURING A HIP ARTHROSCOPY SURGERY ON (B)(6) 2018. IT WAS REPORTED THAT THE DEVICE FRAGMENT/COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THIS EVENT. FURTHER INFORMATION OBTAINED 18JUN2018 FOUND THAT THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION AND THE PATIENT IS LISTED AS HEALTHY. THE PROCEDURE WAS COMPLETED AS NORMAL. 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 7628379 ↗