EXPLOR MODULAR RADIAL HEAD

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. H6: PROPOSED ANNEX G CODE: MECHANICAL (G04) - HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IMMEDIATE POST-OPERATIVE AND UNKNOWN FOLLOW-UP DURATION LATERAL VIEWS OF THE ELBOW AFTER RADIAL HEAD REPLACEMENT. THE PRESUMED FOLLOW-UP IMAGE SHOWS PROXIMAL RADIAL NECK RESORPTION, A WELL-KNOWN PHENOMENON, PARTICULARLY RELATED TO PRESS-FIT RADIAL STEMS. THERE IS A SMALL FOCUS OF HETEROTOPIC OSSIFICATION ANTERIOR TO THE ARTHROPLASTY COLLAR. NO OTHER FINDINGS OF LOOSENING ARE IDENTIFIED. OPERATIVE NOTES WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED NO RELEVANT FINDINGS FOR THE REVISION PROCEDURE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING FOR PART 11-210042. FOR HETEROTOPIC OSSIFICATION: THE REPORTED EVENT WAS DETERMINED TO BE UNRELATED TO THE REPORTED PRODUCTS. EVENT WAS CONFIRMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). D10: ITEM# 11-210063; LOT# 355530. G2: FOREIGN - EVENT OCCURRED IN NORWAY. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AGO. SUBSEQUENTLY, THE PATIENT EXPERIENCED POSSIBLE LOOSENING OF RADIAL STEM, RADIAL PAIN, AND EXTENSION DEFICIT 30 DEGREES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: A1; B4; B5; D2; G1; G3; G6; H1; H2; H10. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AGO TO REPAIR THE FRACTURING OF THE PATIENT'S NATIVE RADIAL HEAD AFTER EXPERIENCING A TRAUMA. SUBSEQUENTLY, THE PATIENT EXPERIENCED POSSIBLE LOOSENING OF RADIAL STEM, RADIAL PAIN, AND EXTENSION DEFICIT 30 DEGREES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.