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POLARSTEM 75102209Recalls & reported problems

Smith & Nephew, Inc. · POLARSTEM COLLAR LATERAL NON-CEMENTED WITH Ti/HA 9 · Class 2 · Implant

All models of POLARSTEM (63)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996152692), received between Oct 11, 2022 and Oct 11, 2022 — 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Fall1
  • Hematoma1
  • Unspecified Infection1
  • Wound Dehiscence1
  • Wound Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2018 TO ADDRESS A DIAGNOSIS OF ADVANCED DEGENERATION OF THE HIP JOINT, THE PATIENT SUFFERED A FALL THREE (3) WEEKS AFTER THE PRIMARY SURGERY. FIVE (5) DAYS LATER, THE PATIENT SUSTAINED A WOUND DEHISCENCE AND DEVELOPED AN INFECTION. A TWO-STAGE REVISION SURGERY WAS NECESSARY TO TREAT THIS COMPLICATION. DURING THE FIRST PROCEDURE CONDUCTED ON (B)(6) 2018, THE PATIENT UNDERWENT AN INCISION & DRAINAGE, FOLLOWED BY AN ADDITIONAL INCISION & DRAINAGE WITH A GIRDLESTONE PROCEDURE ON (B)(6) 2018 DURING WHICH THE FEMORAL STEM WAS REMOVED. THE PATIENT UNDERWENT REIMPLANTATION OF NEW PROSTHESIS COMPONENTS ON (B)(6) 2018 WITH A REDAPT REVISION FEMORAL STEM, AN OXINIUM FEMORAL HEAD AND AN R3 ACETABULAR SYSTEM. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Fall; Hematoma; Unspecified Infection; Wound Dehiscence; Wound Infection

    MAUDE report 15579815 ↗

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

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page