ANATOMIC SHOULDER PROSTHESIS

Description of Event or Problem

THE PATIENT HAD PRIMARY LEFT SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO INSTABILITY AS THE RESULT OF A LOOSE BASEPLATE. THE CONFIRMED CAUSE IS INFECTION WITH THE PATHOGEN UNKNOWN. THE SURGEON TOOK CULTURES FOR TESTING AND REVISED THE REVERSE SHOULDER TO ANATOMICAL WITH ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO CONTINUED SIGNS OF INFECTION WITH THE PATHOGEN UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND CONVERTED THE PATIENT BACK TO A REVERSE SHOULDER SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 2 JULY 2026 ANATOMICAL SHOULDER SYSTEM 04.01.0028 HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135° -11 (K170910) LOT 2349404: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2024. EXPIRATION DATE: 07-APR-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ANATOMICAL SHOULDER SYSTEM 04.01.0091 METAL HUMERAL HEAD D 42 (K170910) LOT 2341999: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2024. EXPIRATION DATE: 19-FEB-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.