Catalog Number 114020046 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Inflammation (1932); Muscle/Tendon Damage (4532)
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Event Date 06/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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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Clinical adverse event received for biceps tendonitis after tenodesis.Event is not serious and is considered mild.Event is possibly related to device and procedure.Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2020, (right shoulder).Treatment: medical intervention/modification (details unspecified).
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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.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: dhr was reviewed.1) quantity manufactured: (b)(4).2) date of manufacture: 18-dec-2017.3) any anomalies or deviations identified in dhr: none.4) expiry date: 30-nov-2027.5) ifu reference: 1140-20-046.
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Search Alerts/Recalls
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