(b)(4).Concomitant medical products: biomet lactosorb l-plate right- regular catalog #: 915-2101 lot #: ni, biomet 2.0 x 7mm lactosorb screw catalog #: 915-2301 lot #: ni.Therapy date: (b)(6) 2018.Foreign country - (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00493 and 0001032347-2018-00494.
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There was a revision performed in which the implants were removed, therefore the complaint is considered confirmed.A picture of the explants was provided in which there appears to be a fragment of these implants with adherent tissue, however no conclusion can be reached as to the identity of this fragment or cause of this complaint due to the limited content of the picture.Functional testing and inspections could not be performed due to the parts not being returned.However, osteolysis, or bone resorption was reported to have been observed twice on this patient, and the reason for this revision.Also, the patient's initial surgery 4 apr 2017 was a le-fort 1 osteotomy which is done to correct facial deformities.This information indicates that the most likely underlying cause of the complaint is patient condition as there was no specific allegation made against the implants.Device history record (dhr) review was unable to be performed as the lot numbers of the devices involved in the event are unknown.The instructions for use (ifu) has the following information for which the product should not be used under the section titled contraindications: patient conditions including, blood supply limitations, insufficient quantity or quality of bone stock or latent infection.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00493-1 and 0001032347-2018-00494-1.
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