UNKNOWN RETRACTOR

Additional Manufacturer Narrative

B3: UNKNOWN DATE IN 2021. D10: ALTEON HA COLLARED STEM SIZE: 11. ALTEON CUP, CLUSTER-HOLE 56MM. ALTEON NEUTRAL LINER. BIOLOX DELTA FEMORAL HEAD, 12/14 TAPER 36MM. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL HIP REPLACEMENT ON THE LEFT SIDE, DURING WHICH THE PATIENT EXPERIENCED AN INTRA-OPERATIVE POSTEROLATERAL CALCAR CRUMBLE CAUSED BY A RETRACTOR. NO MEDICAL INTERVENTION AND NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION AVAILABLE.

Additional Manufacturer Narrative

UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY, NOR WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE REPORTED MALFUNCTION WERE TO RECUR. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE BY EXACTECH AND THIS REPORT MAY BE DISREGARDED.