POLARSTEM 75000675Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556535578), received between Apr 7, 2022 and Apr 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K130728); 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.

• MalfunctionApr 7, 2022Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, THE TIP OF A POLARSTEM STEM IMPACTOR BROKE OUTSIDE THE PATIENT. NO PIECES FELL INTO PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048319 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130728. One submission often covers many models, so check the product and lot details in each record.

• Z-3100-2017 · Jul 24, 2017 · Terminated
  smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction w