Catalog Number 110003450 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 001825034-2023-01469, g2: norway.D10: cat #: 110010247 / g7 osseoti 4 hole shell 58mm g / lot #: 7261707.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that during the procedure, the inserter was unable to be unscrewed from the shell after being implanted.These items were removed, and replaced with a competitor shell with no further complications.It was reported that no further information is available.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The complaint is unable to be confirmed as no product was returned or pictures provided.Device history record (dhr) was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause is unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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