Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Ossification (1428); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -00091.
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Event Description
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It was reported by the 411 group that a patient underwent total hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision on an unknown day for an unknown reason.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.A2: unknown day/month in 1955.Reported event was unable to be confirmed due to limited information received from the customer.X ray was provided and reviewed.Review of the available records identified the following: anatomic alignment of the left hip arthroplasty implants without acute abnormality.Osseous proliferation at the greater trochanter and a small amount of lateral heterotopic ossification as noted.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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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Search Alerts/Recalls
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