Series 7000 7493-0915Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327035582), received between Sep 24, 2018 and Sep 24, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K914565); 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 18, 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.

• InjurySep 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, "FEELS PAIN IN HIS KNEE ALL THE TIME". UPDATE PER MEDICAL REVIEW: AFTER THE SECOND STAGE IMPLANTATION ON (B)(6) 2000 FOR INFECTION THE CLINICIAN NOTED ¿. ON (B)(6) 2000 THE SECOND-STAGE REVISION OF THE LEFT TOTAL KNEE WAS PERFORMED FOR WHICH THE OPERATIVE REPORT DESCRIBES SPINAL ANESTHESIA AND A FIFTY-SIX MINUTE TOURNIQUET TIME. THE COMPONENTS INSERTED WERE A #9 TS III FEMORAL COMPONENT WITH A 105/16 STEM, A #9 PS III TIBIA WITH A 55-MILLIMETER EXTENSION, AND A IS­ MILLIMETER PS III INSERT.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 7903778 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K914565. One submission often covers many models, so check the product and lot details in each record.

• Z-0926-2024 · Dec 1, 2023 · Open, Classified
  TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324