LOQTEQ® DISTAL FEMUR PLATE

Additional Manufacturer Narrative

THE IMPLANT WAS NOT AVAILABLE FOR CAUSE ANALYSIS. THE IDENTIFICATION OF THE IMPLANT (BATCH CODE) WAS NOT PROVIDED. ACCORDING TO THE AVAILABLE X-RAY IMAGE AFTER IMPLANT FAILURE, A CLEAR GAP BETWEEN THE BONE FRAGMENTS AND CALLUS FORMATION ON THE SIDE OPPOSITE THE IMPLANT IS CLEARLY VISIBLE. ACCORDING TO THE AVAILABLE X-RAY IMAGE FOLLOWING IMPLANT FAILURE, A CLEAR BORDER BETWEEN THE BONE FRAGMENTS AND CALLUS FORMATION ON THE SIDE OPPOSITE THE IMPLANT ARE CLEARLY VISIBLE. EXPERT OPINION: OVERALL, THE BONE SHOWS CLEAR SIGNS OF ATROPHIC PSEUDARTHROSIS 6 MONTHS POSTOPERATIVELY. PRESUMABLY CAUSED BY TOO MANY SCREWS IN THE FRACTURE AREA, THIS MAY HAVE LED TO REDUCED BLOOD FLOW AND, AS A RESULT, A LACK OF REVASCULARIZATION. THE IMPLANT IS NOT DESIGNED FOR SUCH CASES OF PROLONGED LACK OF BONE HEALING WITHOUT BONY SUPPORT. . FURTHERMORE, IT IS VERY LIKELY THAT THE PATIENT, ALSO DUE TO HER AGE, WAS UNABLE TO BEAR PARTIAL WEIGHT ADEQUATELY. ACCORDING TO THE USER, PARTIAL WEIGHT-BEARING WAS LIMITED TO THE FIRST TWO WEEKS POSTOPERATIVELY. THE HIGH FORCES OVER A LONG PERIOD OF TIME ULTIMATELY AND INEVITABLY LED TO PERMANENT FAILURE OF THE IMPLANT. NO IMPLANT-RELATED CAUSES COULD BE IDENTIFIED.

Description of Event or Problem

THE DISTAL FEMUR PLATE BROKE SIX MONTHS AFTER SURGERY WITHOUT BONE HEALING.