POLARCUP 75018959Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996111491), received between Nov 12, 2019 and Mar 29, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110135, 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.

• MalfunctionMar 29, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED DURING A THR SURGERY, PROBLEMS WITH THE PACKAGING OF THE POLARCUP XLPE INSERT 55/28 NON CEM DEVICE WERE OBSERVED AS THERE WAS A HOLE IN THE FIRST PACKAGE AND THE FINAL PACKAGE WAS NOT OPEN FROM THE V SHAPE WHERE THE OPENING STARTS FROM, AND IT WAS UNSEALED AND TOTALLY OPEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 16634990 ↗
• 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: Unspecified Infection

  MAUDE report 11692502 ↗
• 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 9313360 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110135, 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.