POLARCUP 75023819Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611996115451), received between Feb 3, 2020 and Feb 9, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2024Break; Solder Joint Fracture; Break; Solder Joint Fracture

  IT WAS REPORTED THAT, IN A THR SURGERY, THE TIP OF THE POLARCUP SHELL POSITIONER WAS UNSOLDERED AFTER IMPACTING THE FINAL IMPLANT. THE PROCEDURE HAD BEEN COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675780 ↗
• MalfunctionJun 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THR SURGERY, THE TAB WAS UNWELDED ON TWO (X2) POLARCUP SHELL POSITIONER. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122192 ↗
• InjuryJun 10, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO FALL OFF IMPACTOR AFTER FOLLOWING THE PROPER INSTRUCTIONS. THE HEAD DOESN'T MATE TO THE INTRODUCER CORRECTLY AND THE THREADS COULD BE DAMAGED ON THE IMPACTOR. IT IS NOT KNOWN IF ALL THESE PROBLEMS OCCURRED DURING THE SAME PROCEDURE AND WHERE (INSIDE OR OUTSIDE OF THE PATIENT). SURGERY WAS COMPLETED CHANGING THE SURGICAL TECHNIQUE.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 10137000 ↗
• InjuryFeb 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT INTERVENTION, THE CUP FELL OUT OF THE TIGHT CUP HOLDER. IT FELL TO THE FLOOR. THE INCIDENT OCCURRED DURING THE PROCEDURE. ACCORDING TO THE SALES REP, THIS EVENT HAPPENED DUE TO A HANDLING MISTAKE. TO COMPLETE THE PROCEDURE, A LARGER SIZE WAS MILLED FOR A T59 CUP BECAUSE THERE WAS NO OTHER T57 CUP IN STOCK. HENCE, ADDITIONAL BONE WAS REAMED TO FIT THE AVAILABLE CUP. THERE WERE NO FURTHER CONSEQUENCES FOR THE PATIENT AND THE PROCEDURE WAS NOT DELAYED.

  Patient problems: Injury

  MAUDE report 9659782 ↗