Catalog Number UNK KNEE |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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It was reported that patient left a voicemail for one of my team member.He didn¿t leave any information except that he had a knee replacement twice.
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Manufacturer Narrative
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Product complaint #: (b)(4).The patient states he has a depuy knee but is unclear which adverse events are associated with which depuy product.Therefore, the allegation will be captured as one unknown knee implant and the complaint will be updated when medical records are received.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Upon further review, it has been determined that there is no allegation against the device, no reportable event.Further updates will only be provided if additional information is received that changes the regulatory determination.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation was not possible, as the required lot number was not provided.The information received, will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre) was not possible, because the required lot code was not provided.
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Search Alerts/Recalls
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