SMITH & NEPHEW, INC. BIOINDUCTIVE IMPLANT W/ARTH DEL LRG; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
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Model Number 4566 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Pain (1994)
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Event Date 09/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: case-(b)(4).
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Event Description
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It was reported that, approx.6 months post-operation, the patient returned to the clinic reporting pain and inflammation.The patient said a mattress hot his shoulder.The mris showed inflammation and the presence of rice bodies around the repair site.A recent mri looked good and normal, rice bodies and inflammation were gone.Patient had an infection and recovered following antibiotics.No follow-up surgery/washout was scheduled.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).Corrected information in d1, d2, d4 (catalog & udi), and g4 (510k).
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Manufacturer Narrative
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H10: h2: additional information: h6: health effect - impact code.H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined.Due to the limited clinical information provided.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was 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.A clinical review states that no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Based on the limited information provided a thorough medical assessment could not be performed; therefore, we are unable to conclude specific factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.
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