HIP INSTRUMENTS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 29 SEPTEMBER 2025. LOT 1112087AA-SN0(B)(6): (B)(4) ITEM MANUFACTURED AND RELEASED ON 10-JUL-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. CONCLUSIONS: SPECIFIC PATIENT CONDITIONS AND UNIQUE SURGICAL FACTORS LIKELY RESULTED IN THE ISSUE REPORTED. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

PRIMARY SURGERY PERFORMED ON (B)(6) 2025. THE PATIENT EXPERIENCED PAIN IN THE LOWER LEG IMMEDIATELY AFTER SURGERY. ALTHOUGH THE CONDITION WAS MONITORED, THE PAIN DID NOT IMPROVE; THEREFORE, AN X-RAY WAS PERFORMED. THE X-RAY REVEALED THREE FRACTURES: A SPIRAL FRACTURE OF THE DISTAL TIBIA; A FRACTURE OF THE PROXIMAL FIBULA, AND A FRACTURE OF THE DISTAL FIBULA (LATERAL MALLEOLUS). ACCORDING TO THE SURGEON, THESE FRACTURES MAY HAVE BEEN CAUSED BY THE MANIPULATION OF THE LEG POSITIONER DURING EXTERNAL ROTATION AND EXTERNAL ROTATION COMBINED WITH EXTENSION. INTRAMEDULLARY NAILING OF THE LOWER LEG WAS PERFORMED ON (B)(6) 2025. ADDITIONAL INFO REGARDING THE BONE QUALITY OF THE PATIENT: XRAYS ARE NOT AVAILABLE BUT IT HAS BEEN REPORTED THAT THE CORTICAL BONE APPEARS THIN.