CRF II - RADIAL PROSTHESIS DTJ022Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700386901249), received between Mar 1, 2017 and Oct 17, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (2 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; 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. THIS RECORD 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. STRYKER REFERENCE # (B)(4) IS COVERING THIS REVISION SURGERY."

  Patient problems: Perforation

  MAUDE report 20468780 ↗
• 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 20462823 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WELBOW STUDY SUBJECT (B)(6): ONE MONTH AFTER THE SURGERY INVOLVING THE CRF II IMPLANT, HETEROTOPIC OSSIFICATION WITH NEUROPATHIC PAIN WAS OBSERVED. IT WAS OBSERVED A NEUROPATHIC PAIN STARTING FROM THE ELBOW AND RADIATING THROUGH THE RIGHT UPPER LIMB. TO ADDRESS THIS ISSUE REHABILITATION AND PHYSICAL THERAPY WERE REQUIRED."

  Patient problems: Extraskeletal ossification; Implant Pain

  MAUDE report 20451843 ↗
• InjuryApr 4, 2024Malposition of Device; Malposition of Device

  AS REPORTED: "FOLLOWING THE SURGICAL INTERVENTION FOR THE RADIAL HEAD CRF II IMPLANT, THE PATIENT EXPERIENCED POSTOPERATIVE COMPLICATIONS, INCLUDING ELBOW STIFFNESS AND IMPLANT MISPOSITIONING. ACCORDING TO THE SURGEON, THIS EVENT HAS A CAUSAL RELATIONSHIP WITH THE SURGERY PROCEDURE BUT IS NOT RELATED TO THE IMPLANT. TO ADDRESS THIS MATTER COMPREHENSIVELY, A CORRECTIVE RE-OPERATION WAS CONDUCTED ON (B)(6) 2020. THIS INVOLVED THE EXTRACTION OF THE EXISTING IMPLANT AND THE SUBSEQUENT RE-IMPLANTATION OF A NEW PROSTHESIS. THE PROCEDURE SUCCESSFULLY RECTIFIED THE COMPLICATIONS, AND THE PATIENT'S CONDITION WAS RESOLVED WITHOUT SEQUELAE."

  Patient problems: Loss of Range of Motion

  MAUDE report 19040000 ↗
• MalfunctionMar 1, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT THE RADIAL HEAD OF THE PROSTHESIS WAS DISASSEMBLED FROM THE STEM AT 6 WEEKS POST OPERATIVELY.

  Patient problems: Failure of Implant

  MAUDE report 6367482 ↗