Where lot numbers were received for the device, the device history record were reviewed and found to be conforming the device has not been received for investigation as the patient has not been revised.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¿s reference number of this file is (b)(4).Note: this is a split case with the zimmer inc.(b)(4), mfr#1822565-2016-00885.
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It is reported, that a patient was implanted with a anatomical shoulder reverse, screw system, 4.5-42 on (b)(6) 2013.It is also reported ,that the patient is experiencing drainage of fluid at the incision site.
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An evaluation of the provided information has been made available.Device history records: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event description: it was reported that the patient received a right shoulder total arthroplasty on (b)(6) 2013.After implantation several drainages were performed.The latest drainage was performed on (b)(6) 2014.On (b)(6) 2016 a medical check-up confirmed a no wound healing.The product is still implanted.Review of received data: three post-operative undated x-rays were received showing a right tsa from different perspectives.No signs of loosening or osteolysis observed around the screws.One perspective suggested that the patient has a humeral ossification as it seems that the humeral bone shaft is slightly deformed.However, this does not correlated with the reported event.Implantation report dated (b)(6) 2013: a (b)(6) patient underwent a tsa to right shoulder due to rotator cuff tear arthroplasty with biceps tenosynovitis.The intervention was performed according indications.No conspicuous information found.According to the patient history, the patient underwent several drainage of hematoma occurred post operatively.The patient suffers from coronary artery disease and underwent to mitral valve replacement.Devices analysis: no device analysis could be performed as the product still implanted in the patient.Possible root causes: poor clinical outcome, insufficient function, insufficient rom, soft-tissue damage, loosening (due to higher joint loads) due to over-stuffing of joint due to incorrect selection of implants: it is possible that soft tissue damage occurred during implantation which led to a complicated clinical outcome and continuous drainage; soft tissue and nerve damage, loss of joint function, pain due to surgeon uses too long screws into bone: possible as just one post-operative x-ray received.Cannot be excluded.Loosening, potential for soft tissue damage due to instability, implant damage, luxation due to surgeon inserts and prepares glenoid with implant rotated by 180 degrees around medio-lateral axis: not possible as no signs of loosening observed.As the patient received artificial heart valves it is possible that is treated with anti coagulating medicaments.This may contributed to the difficulties in the healing of the wound.However, due to significant lack of information, it was impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause could not be determined.Zimmer (b)(4) consider this case as closed.Note: this is a split case with zimmer inc.(b)(4).Zimmer's reference number of this file is (b)(4).
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