Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but discarded by the hospital.The investigation is in process.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 a procedure, the alignment pin of the liner impactor broke off, and was left in situ in the patient, as it was not discovered until after wound closure.The physician monitored the fragment for migration.Approximately 6 months post op, the physician removed the fragment from the patient's humerus.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Reported event was confirmed by review of photographs received.Review of x-rays demonstrated a right total shoulder arthroplasty with screw fragment noted along the superior glenoid.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definite root cause cannot be determined with the information provided.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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