POLARSTEM 75018412Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996103496), received between Jun 10, 2022 and Jun 10, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjuryJun 10, 2022Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A HIP REPLACEMENT ON (B)(6) 2021, THE PATIENT EXPERIENCED THIGH PAIN AFTER BEING RUN OVER BY A DOG. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2022 DUE TO ASEPTIC LOOSENING WHERE THE POLARSTEM COLLAR LAT AND THE TI/HA 1WAS REMOVED. THE PATIENT HAD PREVIOUSLY HAD A FEMORAL SHAFT FRACTURE AND THE SCLEROTIC BONE INSIDE THE INTRAMEDULLARY CANAL IS BELIEVED TO BE THE REASON THE STEM DID NOT INTEGRATE PROPERLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14654992 ↗

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