(b)(4).D10: cat# 11-363662, lot# 531590, 36mm cocr mod hd std.Cat# 00630505036, lot# 64389201, liner standard 3.5 mm offset 36 mm.Cat# 00489405010, lot# 64578579, 50mm x 10mm thickness acetabular augment.G2: foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 03613, 0002648920 - 2023 - 00303, 0002648920 - 2023 - 00304, 0002648920 - 2023 - 00306, 0002648920 - 2023 - 00307, 0002648920 - 2023 - 00308, 0002648920 - 2023 - 00309.The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported that a patient was revised approximately two years after a second stage revision due to acetabular loosening.The head, shell, liner, and augment were replaced.Attempts have been made and no further information has been provided.
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records identified the following: an initial right tha was performed with unknown implants.A second stage revision occurred two years later due to infection and zimmer products were implanted.A revision occurred two years later due to the acetabular component loosening.The shell, liner, screws, augment, and femoral head were explanted and replaced with unknown devices.Radiographs identified the following: loosening and slight displacement of the right hip arthroplasty acetabular implant with screw fractures noted.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records and the mmi report confirming the reported event of shell loosening and screw fracture.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.
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