Model Number 1140-20-050 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2020 |
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 foraminotomy surgery (not for the study shoulder) event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2019, date of event: (b)(6) 2020 (right shoulder).
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Manufacturer Narrative
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Product complaint # (b)(4).The complaint database has been updated to state that the adverse event "foraminotomy surgery (not for the study shoulder)" is no longer is possibly related to device or procedure, but has been changed to definitely not related to device or to procedure.Per clinical process, this now indicates that this adverse event no longer meets the definition of a medical device complaint.The adverse event is unrelated to device or procedure, and therefore, there is no contribution by depuy products or procedure towards the adverse event.Clinical database now indicates ae is not related to device or procedure.As a consequence, this complaint will be downgraded and moved to an npi status.
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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 = > the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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