SMR SYSTEM

Description of Event or Problem

A SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO INFECTION. THE SURGEON GAINED ACCESS TO THE SHOULDER AND COLLECTED MULTIPLE SPECIMENS FROM DIFFERENT ANATOMIES AND TISSUES FOR TESTING. ALL IMPLANTS WERE THEN REMOVED, TISSUE DEBRIDEMENT WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF A ZIMMER CEMENT SPACER WHILE TREATING THE INFECTION. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2026. THE SURGEON FOLLOWED THE STANDARD SURGICAL WORKFLOW FOR SHOULDER REVISION. THE EXPLANTED COMPONENTS INCLUDED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.180, LOT 2430739, STER. N. 2400261); SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT 2511800, STER. N. 2500108); SMR REV. HP LAT. LINER MEDIUM (PRODUCT CODE 1362.09.115, LOT 2505487, STER. N. 2500076); SMR SMALL/STD CONNECTOR +2 (PRODUCT CODE 1374.15.322, LOT 2518095, STER. N. 2500155); SMR REVERSE HP GLENOSPH. 44 MM (PRODUCT CODE 1374.50.440, LOT 2512623, STER. N. 2500093); SMR GLENOID PEG TT S/STD #M (PRODUCT CODE 1375.14.662, LOT 2223558, STER. N. 2300112); SMR GLENOID BASEPLATE SMALL (PRODUCT CODE 1375.15.620, LOT 1701022, STER. N. 2300215); BONE SCREW Ø6,5 H.20 MM (PRODUCT CODE 8420.15.010, LOT 2607932, STER. N. 2600069); BONE SCREW Ø6,5 H.25 MM (PRODUCT CODE 8420.15.020, LOT 2515490, STER. N. 2500104). PATIENT IS MALE, 68 YEARS OLD, SEDENTARY, WITH A HISTORY OF SEVERAL PREVIOUS SURGERIES DUE TO INFECTION. EVENT HAPPENED IN AUSTRALIA.

Additional Manufacturer Narrative

INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED DEVICE LOTS AND STERILIZATION LOTS, NO PRE-EXISTING ANOMALIES WERE FOUND IN THE MANUFACTURING DOCUMENTATION RELATED TO THE COMPLAINED COMPONENTS. THIS IS THE FIRST COMPLAINT RECEIVED FOR THE INVOLVED LOTS AND STERILIZATION NUMBERS. A FINAL MDR WILL BE SHARED UPON COMPLETION OF THE INVESTIGATION.