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: 0001032347-2020-00114, 0001032347-2020-00115, 0001032347-2020-00116, 0001032347-2020-00117, 0001032347-2020-00118.Concomitant medical products: 1.5mm system plate l-shape, 3 x 3 hole, 100 degree left, medium, 0.6mm, part# 01-7032, lot# unk, 1.5mm system plate l-shape, 3 x 3 hole, 100 degree right, medium, 0.6mm, part# 01-7033, lot# unk, 1.5mm system high torque (ht) cross-drive screw, 5/pk, part# 95-1504, lot# unk, 1.5mm system high torque (ht) cross-drive screw, 5/pk, part# 95-1505, lot# unk, unknown le fort plate, part# unk, lot# unk.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).
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This follow-up report is being submitted to relay additional information.The event was initially reported with no part number given for a le fort plate, and the part number was provided at a later date.D11 ¿ medical products 1.5mm system lefort plate, flat 0.6mm, part# 01-6480, lot# unk.
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This follow-up report is being submitted to relay additional information.The complaint is confirmed.The products were returned for investigation.The implants showed signs of use.They were discolored, bent, and fractured, which is consistent with the complaint that they had failed post-operatively.It was reported that both left plates were broken after the operation and loosening also occurred on the right side.The two left plates were confirmed to be fractured.The reported right side loosening could not be verified from the information provided, as no x-rays, scans, or physician's reports were received.It was unclear if the reported loosening was in regards to the interface between the screws and patient's bone or the interface between the plate and screws.The dhr could not be reviewed due to the lot number being unknown.There are no indications of manufacturing defects.For this part (95-1504) and the previous one year (from the notification date) regarding a plate fracture or loosening, (b)(4).The most likely underlying cause of the complaint could not be determined.It is possible that the patient's activity level weakened the implants, causing the fractures and loosening.It is also possible that the plates were weakened while bending during the initial surgery, either by over-bending or bending back and forth repeatedly.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.
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