(b)(4).D10 - medical devices: tess glenoid cemented pe s3; item# p1700426; lot# unknown.Tess hum anatomical corolla s3; item# p1700446; lot# unknown.Tess hum stem small; item# p1700128; lot# unknown.G2 - foreign: france.Multiple mdr reports were filed for this event, please see associated reports: 3006946279-2023-00106, 3006946279-2023-00108, 3006946279-2023-00109.The products remain implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified the evacuation of hematoma approximately seven years and six months ago.Implants remain implanted.No other information has been found.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|