POLARSTEM 75102074Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996142341), received between Sep 20, 2017 and Nov 14, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K143739, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THA PERFORMED ON (B)(6) 2022, ON WHICH TRIALS WERE USED TO CONFIRM THE CORRECT SIZE AND INTRAOPERATIVE X-RAYS WERE USED TO CONFIRM THE CORRECT PLACEMENT OF THE POLARSTEM VALGUS TI/HA 2 DEVICE, THE SURGEON IDENTIFIED A LEG LENGTH DISCREPANCY RESULTING FROM THE LARGER IMPLANT, THEREFORE, A REVISION SURGERY WAS PERFORMED AND DOWNSIZED DEVICE WAS IMPLANTED. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unequal Limb Length

  MAUDE report 15789397 ↗
• InjurySep 20, 2017Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE (CALCAR FRACTURE) AND SUBSIDENCE OF THE POLARSTEM. PATIENT FELT PAIN 4 WEEKS PRIOR TO REVISION. NO FURTHER INFORMATION/ DOCUMENTS AND NO EXPLANTS AVAILABLE (DISCARDED).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 6878270 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143739, 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.
• Z-2827-2020 · Jul 22, 2020 · Open, Classified
  POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the