ARTHREX, INC. GLENOID, PE WITH PEG, MEDIUM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number GLENOID, PE WITH PEG, MEDIUM |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Rupture (2208)
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Event Date 06/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported, via the surgical outcome system, that a arthrex shoulder arthroplasty study patient ((b)(6)) was experiencing subscapularis failure.Upon further investigation the following information has been obtained: the patient had a primary procedure on (b)(6) 2016.During that procedure the following devices had been installed: ar-9100-08s humeral stem, ar-9144-19p humeral head and ar-9105-02 glenoid.The patient became symptomatic in early (b)(6) 2020 for subscapular and supraspinatus rupture.Ct scan findings confirmed rotator cuff tear on (b)(6) 2020.A revision reverse shoulder arthroplasty will be scheduled upon resolution of the current covid-19 pandemic.Additional information provided 6/2/2020: revision surgery is scheduled to take place (b)(6) 2020.Additional information provided 6/26/2020: it has been confirmed that the revision surgery took place on (b)(6) 2020 at the same facility and by the same surgeon as the original procedure.The original implants were explanted and the following devices were implanted during the revision: baseplate: ar-9560-24-2 155527.Central screw: ar-9561-30s 155541.Glenosphere: ar-9564-2436-lat 155566.Humeral stem: ar-9501-09p 145616.Suture cup: ar-9502f-36rcpc 139189.Humeral insert: ar-9503s-03 120148.Additional information provided 7/2/2020: the sales rep reported they were unaware this case was a part of the study until the next day after the case was completed.The explanted implants are returning.
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Manufacturer Narrative
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Complaint confirmed, the device was explanted during a revision surgery.The central peg was broken and the device was cracked and damaged.The damage likely occurred during removal of the device.
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Search Alerts/Recalls
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