POLARCUP 75100442Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07611996118339), received between Nov 12, 2019 and Aug 23, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOW DATE, THERE WAS PRESENCE OF HEAVY METALLOSIS CAUSED BY THE DISLOCATION OF THE CERAMIC HEAD. A REVISION SURGERY WAS PERFORMED IN (B)(6) 2024 (EXACT DATE UNKNOWN), IN WHICH ONE (1) POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM AND ONE (1) POLARCUP PE INSERT 55/28 NON-CEM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 20051168 ↗
• MalfunctionOct 16, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A THR SURGERY, IN ONE (1) POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM THE LOCKING SCREW DOES NOT COME OFF. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17939379 ↗
• MalfunctionJul 21, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING THR, A POLARCUP SHELL TI-PLASMA/HA 53 NON-CEM AND POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM, WHEN OPENED, ONE OF THE TWO PROTECTIVE CAPS FOR THE INSERTION OF THE PEGS HAS NOT BEING UNSCREWED, MAKING IT IMPOSSIBLE TO USE. SURGERY WAS PERFORMED, AFTER A DELAY OF MORE THAN 30 MINUTES, WITH A COMPETITOR BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202854 ↗
• InjuryApr 20, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A PATIENT UNDERWENT A 1ST STAGE REVISION HIP ARTHROPLASTY FOR INFECTION. IMPLANTS WERE EXPLANTED AND SENT TO LOCAL PATHOLOGY FOR SONIFICATION/INFECTION IDENTIFICATION. SINUS TRACK FROM SKIN WOUND INTO DEEP TISSUE/JOINT WAS NOTED DURING SURGERY, ALONG WITH 'FOUL ODOUR' AND HEAMOSEROUS OOZE/PUS. TYPE OF BACTERIA NOT KNOWN AT TIME OF SURGERY.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 11692504 ↗
• MalfunctionSep 24, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT BEFORE A THR PROCEDURE THE POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM LUG CAPS WERE FOUND BLOCKED. THE CAPS DO NOT UNSCREW. NO PROCEDURE-RELATED. S+N BACKUP DEVICE AVAILABLE. NO INJURIES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10580931 ↗
• MalfunctionNov 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A CUP INSTALLATION, A PROBLEM WAS ENCOUNTERED WHEN REMOVING ONE OF THE PLUGS THAT COVER THE HOLES FOR THE ANCHOR STUDS. THE COVER COULD NOT BE REMOVED AND THE ACETABULUM WAS NOT PLACED. A COMPETITOR DEVICE WAS USED TO COMPLETE THE PROCEDURE AND NO DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9378767 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE CONSEQUENCES OF HIS RIGHT HIP REPLACEMENT, STILL EXHIBITING A JUMP PHENOMENON THAT ALMOST PERMANENTLY INVALIDATES AND HINDERS OVERALL RECOVERY.

  Patient problems: Injury

  MAUDE report 9313356 ↗

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.