UNKNOWN OXFORD FEMORAL COMPONENT
Received Jul 26, 2022 · Event occurred Jun 27, 2022
Report 3002806535-2022-00340 · MDR key 15102888
Device
Generic name
Knee Prosthesis
Manufacturer
Biomet Uk Ltd.Model number
N/ACatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Unknown
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PATIENT UNDERWENT THE KNEE REVISION SURGERY DUE TO BONE FRACTURE CAUSED BY TRAUMA. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Additional Manufacturer Narrative
(B)(4). REPORT SOURCE: (B)(4). UNKNOWN OXFORD TIBIAL TRAY ITEM#: UNKNOWN, LOT#: UNKNOWN. UNKNOWN OXFORD BEARING ITEM#: UNKNOWN, LOT#: UNKNOWN. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2022 - 00338, 3002806535 - 2022 - 00339, 3002806535 - 2022 - 00340.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. DEVICES ARE USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.