UNK - RADIAL HEAD PROSTHESIS

Description of Event or Problem

ON (B)(6) 2014, THE PATIENT SUFFERED A FALL, THAT RESULTED IN A RADIAL HEAD FRACTURE IN HER RIGHT ARM. ON APRIL 10, 2014, THE PATIENT UNDERWENT SURGERY CONSISTING OF OPEN REDUCTION AND INTERNAL FIXATION OF THE FRACTURE. IT WAS LATER DETERMINED THAT THERE WAS A NON-UNION OF THE RIGHT RADIAL HEAD AND NECK. ADDITIONAL SURGICAL INTERVENTION WAS NECESSARY TO REPAIR AND SECURE THE FRACTURE. ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT RIGHT RADIAL HEAD ARTHROPLASTY WHERE, THE SURGEON IMPLANTED A RADIAL HEAD PROSTHESIS SYSTEM TO REPAIR AND SECURE THE FRACTURE. THE PATIENT EXPERIENCED AN ACHY FEELING, DISCOMFORT, PAIN AND A LIMITED RANGE OF MOTION IN THE ELBOW. ON (B)(6) 2023, PHYSICIANS DETERMINED THAT THE RADIAL HEAD PROSTHESIS SYSTEM IMPLANTED DURING THE 2014 SURGERY HAD LOOSENED AND WAS OTHERWISE DEFECTIVE. THE RADIAL HEAD PROSTHESIS SYSTEM SUBSEQUENTLY FAILED, LOOSENED, AND HAS CAUSED THE PATIENT TO EXPERIENCE A DEGRADATION OF CORTICAL BONE, TENDERNESS, CHRONIC PAIN, AND OCCASIONAL MECHANICAL SYMPTOMS SUCH AS SNAPPING AND CRACKING.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: E1: REPORTER IS A LEGAL REPRESENTATIVE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, (01)GTIN IS NOT AVAILABLE.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H3, H6: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: ADDED: A1, A2 (DOB), B6, B7. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.