OFFSET MODULAR HUMERAL HEAD 21 MM HEAD HEIGHT 46 MM SPHERICAL HEAD DIAMETER

Additional Manufacturer Narrative

REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS AND MEDICAL RECORDS PROVIDED. X-RAY DATED (B)(6) 2015; REPORT: THREE VIEWS OF THE LEFT SHOULDER DEMONSTRATE SLIGHT INCREASED LUCENCY ABOUT THE PATIENT'S GLENOID IMPLANT COMPONENT. THE PROSTHESIS ITSELF APPEARS IN NEAR ANATOMIC POSITION. HOWEVER, THERE IS CALLOUS FORMATION ABOUT THE LATERAL CORTEX OF THE PROXIMAL LEFT HUMERUS NEAR THE REMNANT OF THE GREATER TUBEROSITY, WHICH MAY REPRESENT A PERIPROSTHETIC FRACTURE SUBACUTE TO REMOTE" X-RAY DATED (B)(6) 2015; REPORT: AP AND OUTLET VIEWS OF THE LEFT SHOULDER ARE SUBMITTED FOR FOLLOW-UP OF TOTAL SHOULDER ARTHROPLASTY. THIS SHOWS A TOTAL SHOULDER WITH SOME HIGH RIDING OF THE HUMERAL HEAD RELATIVE TO THE GLENOID. NO ACUTE LESIONS ARE NOTED. THE SHOULDER IS LOCATED." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN GLENOID. UNKNOWN HUMERAL STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2017 - 05479, 0001822565 - 2017 - 05480. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY 4 MONTHS POST-IMPLANTATION DUE TO PAIN AND LOSS OF RANGE OF MOTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION THE FOLLOWING SECTIONS WERE UPDATED: DATE OF REPORT, BRAND NAME, CATALOG #, LOT # AND EXPIRATION DATE, DATE RECEIVED BY MANUFACTURER, FOLLOW-UP TYPE, DEVICE MANUFACTURING DATE.