POLARSTEM 75018415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996103526), received between Nov 4, 2020 and Jun 5, 2023 — classified as 2 injuries.

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

• InjuryJun 5, 2023Fracture; Fracture

  US LEGAL CASE: IT WAS REPORTED THAT, AFTER UNDERGOING TOTAL LEFT HIP REPLACEMENT ON (B)(6) 2019, THE PATIENT EXPERIENCED SUDDEN PAIN AND A SUBSEQUENT FALL ON (B)(6) 2022. THAT SAME DAY, HE WAS TAKEN TO THE HOSPITAL, WHERE X-RAYS REVEALED A DISPLACED FRACTURE THROUGH THE FEMORAL NECK COMPONENT WITHOUT EVIDENCE OF PROXIMAL FEMUR FRACTURE. THIS EVENT WAS TREATED BY PERFORMING A TOTAL REVISION SURGERY ON (B)(6) 2022. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s); Failure of Implant; Fall

  MAUDE report 17060124 ↗
• InjuryNov 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO CONSTANT DISLOCATIONS. THE SURGEON ATTEMPTED TO REPLACE THE LINER AND ADD 3 SCREWS AND A R3 LINER TO OBTAIN STABILITY BUT WAS NOT ACHIEVED. AFTER THIS THE CUP WAS REMOVED AND ALSO THE STEM. THE FINAL RESULT WAS SUCCESSFUL AND THE WOUND WAS CLOSED.

  Patient problems: Joint Dislocation

  MAUDE report 10788682 ↗

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