Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being 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: 0001032347-2020-00629, 0001032347-2020-00631, 0001032347-2020-00632, 0001032347-2020-00633.Explantation date ¿ the customer reported two dates for the revision surgery: (b)(6) 2020.Clarification was requested from the customer and no response has yet been received.Medical products: 2.0 lactosorb system l-plate - right - regular, part# 915-2101, lot# 835610.2.0 lactosorb system straight plate - 6 hole, part# 915-2109, lot# 956850.2.0 lactosorb system straight plate - extended - 4 hole, part# 915-2111, lot# 145750.2.0 lactosorb system straight plate - extended - 4 hole, part# 915-2111, lot# 372990.2.0 lactosorb system straight plate - extended - 6 hole, part# 915-2112, lot# 499780.The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6.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 records and sterile certificates 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 specified device caused any patient 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.
|