Model Number 1035-44-000 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported that the self centering bipolar did not seem to snap in like normal and had more toggle than usual.Doctor was afraid to implant these 2 components (poly and shell) in the patient in case they were defective.Doe: (b)(6) 2020 right side.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: examination of the returned device is unable to confirm the complaint.The investigation is unable to determine a root cause for the problem experienced by the user.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: j4814a.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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