Medical products: anatomical shoulder reverse, screw system, 4.5-36; catalog#: 01.04223.036; lot#: 2973153.Glenosphere 36 mm diameter; catalog#: 00-4349-036-11; lot#: unknown.Base plate cannulated drill 6 mm diameter 15 mm length; catalog#: 47-4309-061-15; lot#: unknown.Therapy date: (b)(6) 2021.The manufacturer did receive per for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient was implanted with a trabecular metal¿ reverse shoulder system on (b)(6) 2019.After a fall, the patient visited the surgeon and the x-ray control revealed loosening of the glenosphere component, due to which the patient underwent revision on (b)(6) 2021.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, a visual evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet, see surgical technique.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient was implanted with a trabecular metal¿ reverse shoulder system on (b)(6) 2019.After a fall, the patient visited the surgeon and the x-ray control revealed loosening of the glenosphere component, due to which the patient underwent revision on (b)(6) 2021.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Neither the devices nor medical records have been received; therefore, an investigation of the reported event could not be performed, hence the reported event cannot be confirmed.Nevertheless, based on the provided event description, it can be assumed that the patient fall led to the reported loosening of the glenosphere and subsequently to the revision.There is no indication of any cause related to the screws.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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