GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM

Additional Manufacturer Narrative

DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE IS NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO PERIPROSTHETIC FRACTURE AND INFECTION. REVISED COMPONENTS ARE "21+30 CONE BODY, 20X267 PLASMA STEM, 28 BIOLOX HEAD, 42E MDM INSERT". REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL'S HIPAA POLICY.

Additional Manufacturer Narrative

THE REPORTED EVENT THAT GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM WAS ALLEGED OF 'INFECTION' COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. NO DEVIATION WAS FOUND IN THE PACKAGING & STERILIZATION PROCESSES. THE ITEMS WERE DOCUMENTED FAUTLESS PRIOR TO DISTRIBUTION. FURTHER, THE EXPIRATION DATE OF ALL REPORTED PRODUCTS WAS NOT EXCEEDED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO PERIPROSTHETIC FRACTURE AND INFECTION. REVISED COMPONENTS ARE "21+30 CONE BODY, 20X267 PLASMA STEM, 28 BIOLOX HEAD, 42E MDM INSERT". REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL'S HIPAA POLICY.