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ACCURIS 71236012Recalls & reported problems

Smith & Nephew, Inc. · ACCURIS TIBIAL INSERT HANDLE · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010589897), received between Apr 9, 2019 and Apr 4, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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

Device problems

  • Break3
  • Loose or Intermittent Connection1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 4, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT, DURING SET UP FOR A JOURNEY UNI, WHEN PLACING THE INSERT ON THE HANDLE, THE INSERT WAS LOOSE AND WOULDN¿T STAY PROPERLY. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND THERE WAS NO DELAY OR FURTHER COMPLICATIONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11611975 ↗
  • MalfunctionFeb 16, 2021Break; Break

    IT WAS REPORTED THAT, DURING PROCEDURE ACCURIS TIBIAL INSERT HANDLE BROKE IN HALF WHILE TRYING TO PLACE INSERT. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30MIN CHANGING THE SURGICAL TECHNIQUE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11331776 ↗
  • MalfunctionFeb 17, 2020Break; Break

    IT WAS REPORTED THAT DURING THE PROCEDURE THE ITEM BROKE INSIDE OF THE PATIENT. SURGERY WAS NOT DELAYED AND IT IS NOT KNOWN IF THERE WAS AN S AND N BACKUP DEVICE AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9717445 ↗
  • MalfunctionApr 9, 2019Break; Break

    IT WAS REPORTED THAT DURING SURGERY, THE DEVICE WAS NOTICED TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH NO DELAY OR PATIENT INJURIES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8497178 ↗

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.