CRF II - RADIAL PROSTHESIS DTJ008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386901225), received between Oct 16, 2024 and Oct 16, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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.

• InjuryOct 16, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WELBOW STUDY SUBJECT : (B)(6). DURING THE SURGERY INVOLVING THE CRF II IMPLANT, AN INTRA-OPERATIVE COMPLICATION WAS OBSERVED. THE PATIENT EXPERIENCED A DEFECT IN THE RADIAL BONE CUT. THIS EVENT WAS REPORTED AS A SERIOUS ADVERSE EVENT THAT REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE. IN MEDICAL OBSERVATION: INDICATION TO REPEAT THE CUT OF AT LEAST 3MM, CEMENTATION OF A NEW STEM, REINSERTION OF THE EXTERNAL COLLATERAL PLANE, PROCEDURE: CHANGE OF LEFT RADIAL HEAD PROSTHESIS, 3MM CUT, REINSERTION OF EXTERNAL COLLATERAL PLANE. STRYKER REFERENCE # (B)(4) IS COVERING THIS INTRA-OP COMPLICATION. MANAGEMENT IN THE OPERATING ROOM ON (B)(6) 2024 FOR ARTHROPLASTY OF THE RADIAL HEAD AND REINSERTION OF THE LATERAL PLANE ON ANCHOR. POST-OPERATIVE FOLLOW-UP RADIOGRAPHS SHOWED TOO MUCH PROSTHETIC CROWDING. NEED FOR REVISION SURGERY TO CUT THE NECK OF THE RADIUS AND REIMPLANT A NEW PROSTHESIS. A NEW CRF II IMPLANT WAS USED. THIS RECORD IS COVERING THIS REVISION SURGERY."

  Patient problems: Implant Pain; Insufficient Information

  MAUDE report 20462421 ↗