SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W ARTHRO DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
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Catalog Number 72205307 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 03/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that a rotator cuff surgery was performed with regeneten on (b)(6) 2020 without incident.During the postoperative period, the patient developed an adhesive capsulitis and to free these adhesions, a second surgery was performed on (b)(6) 2021.The implant was perfectly integrated and a layer of tendon-like tissue has been induced.Patient outcome is ok.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the instructions for use found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Search Alerts/Recalls
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