POLARCUP 75100410Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996118018), received between Mar 29, 2019 and Jul 11, 2024 — classified as 3 injuries.

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 (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.

• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED SEPTIC SOCKET LOOSENING. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE POLARSTEM STEM STD TI/HA 2 NON-CEM AND THE POLARCUP XLPE INSERT 51/28 NON-CEM WERE EXCHANGED. THE PATIENT IS INDEPENDENTLY MOBILE WITH TWO WALKING STICKS.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Subluxation; Unequal Limb Length

  MAUDE report 19721616 ↗
• InjuryApr 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A LEFT SIDE THA AT WOLLONGONG PUBLIC (B)(6) 2019 WITH A SPECTRON/POLARCUP CONSTRUCT VIA A POSTERIOR APPROACH. PATIENT HAS MEDICAL HISTORY OF KIDNEY TRANSPLANT. PATIENT LEFT HIP WOUND WOULD NOT HEAL AND WAS INFECTED. PATIENT HAD A WASHOUT AND DEBRIDEMENT (DONE BY ANOTHER SURGEON) AS WELL AS VAC DRESSINGS, PRIOR TO FIRST STAGE REVISION ON (B)(6) 2019. DR. PERFORMED FIRST STAGE REVISION HIP SURGERY ON (B)(6) 2019 REMOVING ACETABULAR IMPLANTS WITH ZIMMER EXPLANT AND USING RENOVATION HIP TO REMOVE FEMORAL COMPONENT. SURGEON PERFORMED AN ETO AND REMOVED CEMENT FROM FEMUR WITH RENOVATION INSTRUMENTS. ACETABULUM REAMED AND FEMUR REAMED. WOUND DEBRIDED AND IRRIGATED WITH SALINE AND BETADINE AND FEMUR CABLED WITH CIRCLAGE WIRE TEMPORARILY. WOUND CLOSED, AND THEN PT RE-PREPPED AND DRAPED WITH WHOLE NEW SETUP. PT THEN REOPENED AND THEN DALLMILES CABLES APPLIED TO FEMUR AND ZB HIP CEMENT SPACER INSERTED WITH PALACOS COPAL CEMENT LOADED WITH ANTIBIOTIC USED TO FIX HIP CEMENT SPACER. WOUND IRRIGATED AND CLOSED IN LAYERS.

  Patient problems: Unspecified Infection

  MAUDE report 8489099 ↗
• InjuryMar 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. PATIENT LEFT HIP WOUND WOULD NOT HEAL AND WAS INFECTED. PATIENT HAD A WASHOUT AND DEBRIDEMENT PRIOR TO FIRST STAGE REVISION ON 7/3/19, ACETABULAR IMPLANTS AND FEMORAL COMPONENT WERE REMOVED. ANTIBIOTIC CEMENT SPACER IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 8465644 ↗

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.