(b)(4).D10- medical products: item#: unknown; lot#: unknown; item name: unknown oxford medium femur; item#: unknown; lot#: unknown; item name: unknown oxford 4mm mobile bearing; item#: unknown; lot#: unknown; item name: unknown cement; item#: unknown; lot#: unknown; item name: unknown 4.0mm cancellous screw.D10 -therapy date: unknown.G2-foreign- japan.G2-literature- journal article.Intraoperative avulsion fracture of the intercondylar eminence in oxford mobile-bearing unicompartmental knee arthroplasty: case report.Akira saitoh, takafumi hiranaka, akihiko arimoto, atsuki tanaka, yoshihito suda, motoki koide, takaaki fujishiro, koji okamoto (2022) https://doi.Org/10.1016/j.Knee.2022.11.017.H3-other: device evaluation could not be performed as part# and lot# unknown.Also device location is unknown.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.An avulsion fracture is the tearing of the tendon off of the insertion point of the bone.The intraop avulsion fracture required additional intervention not in the original treatment plan.Therefore, this event is considered a serious injury.With the available information, a definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00324, 3002806535 - 2023 - 00327.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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