Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00388, 0001032347-2020-00390, and 0001032347-2020-00391.Medical products: tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 891840d.Tmj system left fossa component, small, part# 24-6563, lot# 886880b.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni.Reporter: patient.
|
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00388-1; 0001032347-2020-00390-1; 0001032347-2020-00391-1.H3: product remains implanted in patient.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record and sterile cert for item 24-6563 identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the 24-6563 devices caused any patient infection.The user is required to sterilize the screws prior to the procedure.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.
|