Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
No Information (3190); Insufficient Information (4580)
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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 remains implanted.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 a patient underwent a hip arthroplasty on an unknown date and subsequently, the patient is being considered for a revision on an unknown day for an unknown reason.No revision surgery has been reported to date.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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.A definitive root cause cannot be determined.
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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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