Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 02/19/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 the patient underwent a total shoulder replacement.Subsequently, during the procedure, the glenoid trial fractured, and the patient retained a small piece of plastic.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This report is being submitted to relay corrected data.Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001825034-2018-02410.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of complaint history determined that no further action(s) is/are required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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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