Model Number 1217-25-500 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 07/21/2020 |
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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Empty packing.It was reported that during the surgery of total hip replacement operation, opened the packing (could not find this issue if did not open the packing), noted no product in the packing.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned packaging materials confirms the reported observation.Based on the condition of the inner packaging materials it is difficult to conclude it was distributed in this condition.No error in initial processing is suspected.The information received will be retained for potential series investigations if triggered by trend analysis 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: lot pu154657.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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Search Alerts/Recalls
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