MPACT ACETABULAR SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 16 JULY 2026 BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT. 2418027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2024. EXPIRATION DATE: 10-JUN-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3644HC10A FACE CHANG 10° PE HC LINER D 36/E (K183582) LOT 2115597: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2021. EXPIRATION DATE: 08-NOV-2026. 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 A SECOND REVISION SURGERY WAS PERFORMED APPROXIMATELY 20 MONTHS AFTER THE PREVIOUS REVISION AND ABOUT 27 MONTHS AFTER THE PRIMARY CEMENTLESS THA DUE TO RECURRENT DISLOCATION, WITHOUT REPORTED TRAUMA. THE PATIENT HAD ALREADY UNDERGONE EXCHANGE OF THE FEMORAL HEAD AND LINER FOLLOWING AN EARLIER DISLOCATION APPROXIMATELY SIX MONTHS AFTER THE PRIMARY PROCEDURE. THE ONLY AVAILABLE RADIOGRAPH SHOWS THE PROSTHESIS IN THE DISLOCATED POSITION AND IS OF LIMITED QUALITY; THEREFORE, THE ORIENTATION OF THE ACETABULAR AND FEMORAL COMPONENTS CANNOT BE RELIABLY ASSESSED, AS NO IMAGE OF THE REDUCED JOINT IS AVAILABLE. THE DECISION TO REVISE THE CONSTRUCT TO A DUAL-MOBILITY ARTICULATION SUGGESTS PERSISTENT INSUFFICIENT JOINT STABILITY. THIS MAY HAVE BEEN RELATED TO INADEQUATE SOFT-TISSUE TENSION OR INSUFFICIENCY, OR ALTERNATIVELY TO DIFFICULTIES IN ACHIEVING OPTIMAL COMPONENT ORIENTATION, POTENTIALLY INFLUENCED BY PATIENT-SPECIFIC ANATOMICAL FACTORS THAT CANNOT BE EVALUATED FROM THE AVAILABLE IMAGE. RECURRENT INSTABILITY AFTER THA IS FREQUENTLY MULTIFACTORIAL. BASED ON THE INFORMATION AT HAND, THE EXACT CAUSE CANNOT BE DETERMINED, AND THERE IS NO INDICATION OF A DEFECTIVE OR MALFUNCTIONING DEVICE. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THE RECURRENT DISLOCATION MAY HAVE BEEN RELATED TO CASE-SPECIFIC CLINICAL FACTORS AFFECTING JOINT STABILITY, SUCH AS INADEQUATE SOFT-TISSUE TENSION OR COMPONENT ORIENTATION; HOWEVER, THESE FACTORS CANNOT BE CONFIRMED FROM THE AVAILABLE DOCUMENTATION AND RADIOGRAPHIC EVIDENCE. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

Description of Event or Problem

ON (B)(6) 2024, THE PATIENT HAD PRIMARY RIGHT HIP SURGERY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATION OF THE HEAD AND LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND BIOLOX HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE LINER TO A DOUBLE MOBILITY LINER WITH DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.