(b)(4).D10 ¿ medical devices: unknown metasul bearing; item# unknown; lot# unknown.Unknown metasul head; item# unknown; lot# unknown.Unknown continuum 52 mm uni-hole cup; item# unknown; lot# unknown.G2 ¿ foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00503, 0009613350 - 2023 - 00504, 0009613350 - 2023 - 00505.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : product is unknown.
|
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|