'POLARSTEM¿' 75102253Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556533611), received between Mar 21, 2023 and Mar 21, 2023 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K143739); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING LEFT THA, ONE (1) PATIENT EXPERIENCED UNSPECIFIED EVENTS THAT LED TO A REVISION SURGERY COMBINED WITH INTERNAL FIXATION. THIS SURGERY WAS PERFORMED ON (B)(6) 2021, IN WHICH AN INTRAOPERATIVE FEMUR FRACTURE OCCURRED. AS REMEDIAL ACTION, AN ACCORD CABLE SYSTEM WAS IMPLANTED. A POST-OPERATIVE FOLLOW-UP CONFIRMED A GOOD POSITION WITHOUT COMPLICATING FEATURES.

  Patient problems: Hip Fracture

  MAUDE report 16583202 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143739. One submission often covers many models, so check the product and lot details in each record.

• 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