HEMICAP FEMORAL CONDYLE ARTHROPLASTY

Additional Manufacturer Narrative

THE EU DISTRIBUTOR RECEIVED DEVICE INFORMATION FROM THE HEALTHCARE FACILITY WHICH WAS FORWARDED TO ARTHROSURFACE ON 02/08/2018. THE PART AND LOT NUMBERS OF THE HEMICAP KNEE COMPONENTS IN QUESTION ARE: TAPER POST COMPONENT - PART # 7095-0020; LOT: 75HD0823 - MFG DATE: 08/2014, EXP DATE: 08/2019 ARTICULAR RESURFACING COMPONENT - PART # 7202-1010; LOT: 75ID0435 - MFG DATE: 09/2014, EXP DATE: 05/2021. A COMPREHENSIVE REVIEW OF THE INCOMING AS WELL AS FINAL INSPECTION RECORDS (DHRS) OF THE ABOVE LOTS WERE CONDUCTED AND NOTED THAT ALL PARTS WERE MANUFACTURED TO SPECIFICATION. THERE ARE NO PREVIOUSLY LOGGED COMPLAINTS FOR EITHER OF THE ABOVE COMPONENT LOTS IN QUESTION. SINCE THE PARTS WERE UNABLE TO BE RETURNED AND PATIENT'S CLINICAL HISTORY IS UNKNOWN, AN APPROPRIATE ROOT CAUSE FOR REPORTED LOOSENING CANNOT BE CONCLUDED WITH THE LIMITED INFORMATION AVAILABLE. THE PRODUCT PACKAGE INSERT STATES THAT THIS TYPE OF EVENT CAN OCCUR AND ALL RISKS ARE ADDRESSED IN THE RISK DOCUMENTATION. THE PATIENT WAS REVISED TO A BICONDYLAR PROSTHESIS AND ALL ARTHROSURFACE COMPONENTS HAVE BEEN EXPLANTED.

Additional Manufacturer Narrative

ARTHROSURFACE HAS LIMITED INFORMATION REGARDING THIS CASE FROM THE SOURCE DOCUMENT RECEIVED. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. AS NO PART NUMBER OR LOT NUMBER WERE PROVIDED, THE MANUFACTURING HISTORY OF THE IMPLANT DEVICE(S) INSTALLED IN THE PATIENT COULD NOT BE REVIEWED. THERE WAS NO INDICATION ON THE SOURCE DOCUMENT, WHETHER ONLY ONE IMPLANT DEVICE WAS LOOSE OR BOTH THE IMPLANT DEVICES WERE LOOSE AT THE TIME OF THE REVISION SURGERY. A CAUSE FOR LOOSENING OF THE DEVICE(S) UNDER QUESTION CANNOT BE ASCERTAINED DUE TO AVAILABILITY OF LIMITED INFORMATION. SHOULD ARTHROSURFACE RECEIVE ADDITIONAL INFORMATION REGARDING THIS CASE, A SUPPLEMENTAL MDR WILL BE SUBMITTED ACCORDINGLY. NOTE THAT THIS REPORT IS FOR HEMICAP KNEE 20MM IMPLANT DEVICE, WHICH IS ONE OF THE 2 ARTHROSURFACE DEVICES THAT WERE REVISED IN THE PATIENT. THE REPORT PERTAINING TO OTHER IMPLANT DEVICE (HEMICAP PFXL) IS # 3004154314-2017-00013.

Description of Event or Problem

ARTHROSURFACE WAS NOTIFIED OF THE INFORMATION THAT A PATIENT IMPLANTED WITH ARTHROSURFACE HEMICAP PFXL AND KNEE DEVICES WAS REVISED DUE TO DEVICE LOOSENING. THIS REPORT IS SPECIFIC TO THE HEMICAP KNEE IMPLANT DEVICE WHICH IS NOT CLEARED BY FDA.