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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Urinary Tract Infection (2120)
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Event Date 08/23/2010 |
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.Unique identifier (udi) #: n/a.Concomitant medical products: item # (b)(4), head, lot # unk; item # (b)(4), shell, lot # unk; item # unk, liner, lot # unk; item # unk, taper, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06906; 0001825034-2018-06907; 0001825034-2018-06909; 0001825034-2018-06910.
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Event Description
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It was reported that approximately 2 weeks post implantation, the patient developed a uti and was treated with cipro.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products : item # s031140, head, lot # unk , item # 13-104158, shell, lot # unk , item # unk, liner, lot # unk , item # unk, taper, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 06907-01, 0001825034 - 2018 - 06909-01.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) 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.Complaint search cannot be performed for liner as the part and lot number is unknown.Surgical notes were not provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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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