INJECTABLE CACIUM PHOSPHATE

Additional Manufacturer Narrative

PER INFORMATION PROVIDED THESE IS NO EVIDENCE THAT THIS EVENT IS RELATED OR CAUSED BY ETEX CORPORATION PRODUCT, OR THAT PRODUCT MALFUNCTIONED. THIS EVENT IS REPORTED BECAUSE THERE WAS SERIOUS INJURY REPORTED IN THIS LAWSUIT. THE REPORTED FRACTURE OF TITANIUM TOE IMPLANT (NOT ETEX PRODUCT) IS MOST LIKELY TO CAUSE THE REPORTED PAIN AT NUMEROUS DOCTORS VISITS.

Description of Event or Problem

ON THE 18 JUNE 2019 ETEX RECEIVED THE INFORMATION ABOUT THE LAWSUIT ((B)(6)) INVOLVING ETEX CORPORATION INJECTABLE CALCIUM PHOSPHATE. IT WAS REPORTED PER OPERATIVE NOTES ATTACHED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT SURGERY WITH A STRAYER PROCEDURE AND SECOND METATARSOPHALANGEAL JOINT HEMI-IMPLANT ARTHROPLASTY WITH PERCUTANEOUS K-WIRE INTERNAL FIXATION OF FRACTURED THIRD DIGIT. INJECTION OF CALCIUM PHOSPHATE INTO THE SECOND METATARSAL HEAD DEFECT AND APPLICATION OF POSTERIOR SPLIT, ALL ON THE LEFT SIDE. PER PROGRESS NOTES FROM THE (B)(6) FOOT AND ANKLE MEDICAL CENTER, THE POST OPERATIVE VISIT WAS NORMAL BUT THAT FOLLOWED WITH ADDITIONAL VISITS (STARTING ON (B)(6) 2015) TO THE DOCTOR COMPLAINING ABOUT SWELLING AND PAIN. ON (B)(6) 2016, X-RAYS WERE TAKEN- AP, LATERAL, AND OBLIQUE VIEWS SHOW THE IMPLANT STEM IS IN THE PLACE BUT THERE ARE SOME CHANGES TO THE SECOND METATARSAL HEAD WITH LOOSENING OF THE IMPLANT AND A FRACTURED DIGITAL IMPLANT AT THE INTERFACE OF THE HEAD AND THE SHAFT OF THAT IMPLANT. THE HEAD OF THE IMPLANT IS STILL POSITIONED WITHIN THE JOINT SURFACE, SLIGHTLY LATERALLY DEVIATED, AND DORSI POSITIONED. THERE IS NO INFORMATION PROVIDED THAT SUGGESTS THE FRACTURE OF THE HEMI-IMPLANT OR REPORTED PAIN IS CAUSED BY INJECTABLE CALCIUM PHOSPHATE. THE PROGRESS NOTES FROM THE MEDICAL CENTER. PART NUMBER AND LOT NUMBER OF THE PRODUCT WAS NOT RECEIVED.