POLARCUP 75100440Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996118315), received between Mar 10, 2021 and May 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K122244, K211176); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Mechanical Jam

  IT WAS REPORTED THAT, DURING AN ACETABULAR REVISION SURGERY (UNKNOWN IF FROM S+N IMPLANTS), ON ATTEMPTING TO UNSCREW ONE (1) POLARCUP ANCHORING PEG 2 EACH OF THE PEG HOLE COVERS FROM ONE (1) POLARCUP SHELL TI-PLASMA/HA 51 NON-CEM, THE THREADS CROSS THREADED AND COULD NOT BE REMOVED. THE SURGEON ATTEMPTED TO SEAT A PEG IN THE SECOND, AVAILABLE PEG HOLE AFTER DRILLING THE HOLE AS PER THE TECHNIQUE, BUT THE PEG FAILED TO SEAT FLUSH WITH THE CUP AND HAD TO BE REMOVED. THE PEG HOLE WAS LEFT OPEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112276 ↗
• MalfunctionMay 12, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING B/L THR, ONE PLUG COVER OF THE POLARCUP SHELL TI-PLASMA/HA 51 NON-CEM COULD NOT BE REMOVED AND THE POLARCUP SHELL TI-PLASMA/HA 51 NON-CEM SUFFERED A DEFORMATION WHILE TRYING TO UNPLUGED THE COVER. NO SIGNIFICANT DELAYS WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11814116 ↗
• MalfunctionMar 10, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHEN DOCTOR OPENED POLARCUP SHELL, HE OPENED THE SCREWS TO GET PEGS. NUTS ON THE POLARCUP SHELL CANNOT BE OPENED DESPITE ATTEMPT OF UNSCREWING AND SCREWING FOR OPENING. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11450006 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122244, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.