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 Problems
Pain (1994); Rupture (2208)
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Event Date 09/07/2022 |
Event Type
Injury
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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 after an acl, in which a regeneten bioinductive device was implanted, the patient experienced more pain.A revision surgery is planned.No further complications were reported.
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Manufacturer Narrative
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Following section were updated: b5, h6, health effect - impact code and type of investigation.
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Event Description
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It was reported that after a left rotator cuff repair that took place on (b)(6) 2022, in which a regeneten bioinductive device was implanted, the patient experienced more pain from (b)(6) 2022 due to a re-rupture.A re-operation was performed on (b)(6) and the issue was resolved with this procedure and hospitalization.No further complications were reported.
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Event Description
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It was reported that after a left rotator cuff repair that took place on (b)(6) 2022, in which a regeneten bioinductive device was implanted, the patient experienced more pain from (b)(6) 2022 due to a re-rupture.A re-operation was performed on october 27 and the issue was resolved.No further complications were reported.
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Manufacturer Narrative
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B5, h6 (health effect - clinical code and health effect - impact code) were updated.H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.A clinical review states the finite data provided in the adverse events documents support the complaint; however, the limited information is insufficient to render a thorough medical assessment.Per the provided adverse event form the patient is "recovering" following the procedure.No further medical assessment is warranted at this time.Should additional information be provided, the clinical/medical investigation task will be reopened.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and 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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Search Alerts/Recalls
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