SMR SHOULDER

Additional Manufacturer Narrative

PRELIMINARY REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY PRE-EXISTING ANOMALY POSSIBLY CONTRIBUTING TO REPORTED MALPOSITIONING OF THE BASEPLATE. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

Description of Event or Problem

REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 DUE TO BASEPLATE MALPOSITIONING. THE BASEPLATE WAS IMPLANTED TOO HIGH IN THE PRIMARY SURGERY OCCURRED ON (B)(6) 2025. ORIGINAL ASSEMBLY CONSISTED OF: SMR REVERSE LINER + 6 MM (PART NUMBER 1360.50.820, LOT. 24AT5P8, STERILIZATION N. 2500009). SMR CONNECTOR SMALL STD (PART NUMBER 1374.15.310, LOT. 2500907, STERILIZATION N. 2500027). SMR GLENOSPHERE Ø 36MM (PART NUMBER 1374.09.111, LOT. 2506966, STERILIZATION N. 2500066). SMR METAL-BACK GLENOID SMALL (PART NUMBER 1375.21.020, LOT. 2435106, STERILIZATION N. 2500053). SMR CEMENTLESS FINNED STEM (PART NUMBER 1304.15.210, LOT. 2102161, STERILIZATION N. 2100078). PATIENT UNDERWENT A FIRST REVISION ON (B)(6) 2026 (REPORTED AS MFR 3008021110-2026-00124) BECAUSE THE ABOVE-MENTIONED LINER WAS FOUND LOOSE. DURING REVISION THE LINER WAS REMOVED AND REPLACED WITH ANOTHER FROM THE SAME LOT. AFTER FEW MONTHS PATIENT WAS REVISED AGAIN DUE TO ORIGINAL BASEPLATE MALPOSITIONED. THE SURGEON OPTED TO REMOVE THE PRE-EXISTING GLENOSPHERE AND CONNECTOR AND RE-BUILD A MORE LATERALIZED AND LOWERED CONSTRUCT WITH A CONNECTOR LAT +4MM (PN 1374.15.324) AND ECCENTRICAL GLENOSPHERE DIA40MM (PN 1376.09.041) IN ORDER TO AVOID BASEPLATE REMOVAL SINCE PATIENT IS 82 YEARS OLD. THE REVERSE LINER WAS ALSO REPLACED WITH A RETENTIVE +3MM ONE (PN 1365.50.816). SURGERY WAS COMPLETED AS INTENDED. THE EVENT OCCURRED IN THE UNITED STATES.