SHOULDER SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 29 MAY 2026 REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XD 24.5 (K193175) LOT 2532861: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2026. EXPIRATION DATE: 16-FEB-2031. 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. REVERSE SHOULDER SYSTEM 04.01.0500 HUM. REV. E-CROSS LINER D 36/+3 - LARGE (K250644) LOT 2509206: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2025. EXPIRATION DATE: 08-MAY-2030. 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. CLINICAL EVALUATION: BASED ON THE INFORMATION PROVIDED, THE PATIENT PRESENTED APPROXIMATELY TWENTY DAYS AFTER THE PRIMARY PROCEDURE WITH PAIN DUE TO A DISLOCATION BETWEEN THE GLENOSPHERE AND THE LINER. THERE WAS NO REPORTED TRAUMA ASSOCIATED WITH THIS EVENT. A REVIEW OF THE AVAILABLE RADIOGRAPHIC IMAGES DOES NOT REVEAL ANY ADDITIONAL INFORMATION THAT WOULD CLARIFY THE UNDERLYING CAUSES OF THE DISLOCATION. HOWEVER, EVENTS OF THIS NATURE ARE KNOWN TO COMMONLY ARISE FROM INADEQUATE RESTORATION OF SOFT TISSUE TENSION FOLLOWING THE INITIAL OPERATION. THESE MECHANISMS ARE WELL DOCUMENTED CONTRIBUTORS TO POSTOPERATIVE INSTABILITY AND CAN LEAD TO LINER OR GLENOSPHERE DISLOCATION IN THE ABSENCE OF TRAUMA. WITH THE ELEMENTS CURRENTLY AVAILABLE, NO FURTHER CONCLUSIONS CAN BE DRAWN REGARDING THE EVENT, AND THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THE EVENT APPEARS CONSISTENT WITH POSTOPERATIVE INSTABILITY/DISLOCATION, WHICH IS A LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTY AND MAY OCCUR WITHOUT AN IDENTIFIABLE CAUSE; IN THIS CASE, IT MAY HAVE BEEN RELATED TO CASE-SPECIFIC CLINICAL OR APPLICATION-RELATED FACTORS, SUCH AS INADEQUATE RESTORATION OF SOFT TISSUE TENSION FOLLOWING THE PRIMARY PROCEDURE. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE OR SYSTEMIC DEFICIENCY.

Description of Event or Problem

AT ABOUT 20 DAYS FROM THE PRIMARY,THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION BETWEEN THE GLENOSPHERE AND THE INSERT. THE CAUSE OF THE DISLOCATION IS UNKNOWN, AND THERE ARE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE LATERALIZED GLENOSPHERE 36 X D 24.5 TO A 42 X D 24.5 GLENOSPHERE AND REPLACED THE D 36/+3 LARGE LINER WITH A D 42/+3 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.