SHOULDER SYSTEM

Additional Manufacturer Narrative

CLINICAL EVALUATION BASED ON THE INFORMATION PROVIDED, THE PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY ONE YEAR AND FOUR MONTHS AFTER THE PRIMARY PROCEDURE DUE TO A DISLOCATION AT THE ARTICULATION BETWEEN THE LINER AND THE (COMPETITOR) GLENOSPHERE. NO TRAUMA WAS REPORTED IN ASSOCIATION WITH THIS EVENT. A REVIEW OF THE AVAILABLE RADIOGRAPHIC IMAGE DOES NOT REVEAL ANY ADDITIONAL INFORMATION THAT WOULD CLARIFY THE UNDERLYING CAUSE OF THE DISLOCATION. HOWEVER, EVENTS OF THIS NATURE ARE KNOWN TO COMMONLY ARISE FROM PROGRESSION OF SOFT TISSUE INSUFFICIENCY OVER TIME OR 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. BATCH REVIEW PERFORMED ON 06 JULY 2026 LOT 2402701: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2024. EXPIRATION DATE: 14-MAY-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:BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. DISLOCATION IS A LITERATURE-DESCRIBED ADVERSE EVENT AFTER JOINT ARTHROPLASTY AND MAY BE RELATED TO CASE-SPECIFIC CLINICAL FACTORS, SUCH AS SOFT TISSUE INSUFFICIENCY OR INADEQUATE RESTORATION OF SOFT TISSUE TENSION. THERE IS NO INDICATION OF A DEVICE-RELATED ISSUE, MANUFACTURING ISSUE, OR SYSTEMIC DEFICIENCY.

Description of Event or Problem

REVISION SURGERY DUE TO JOINT LUXATION BETWEEN LINER AND COMPETITOR GLENOSPHERE AFTER ABOUT 1 YEAR AND 4 MONTHS FROM PRIMARY. THE SURGEON REVISED LINER AND METAPHYSIS.