The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under possible adverse effects number 4: ¿loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity.¿ following review, no new risks were identified.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.Emerson jr, r.H., & higgins, l.L.(2008).Unicompartmental knee arthroplasty with the oxford prosthesis in patients with medial compartment arthritis.The journal of bone and joint surgery incorporated, 90-a, 118-122.¿ zimmer biomet complaint number: cmp-(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 1825034¿2017¿08120 / 08125 / 08144 / 08145.Product location unknown.
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