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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Impaired Healing (2378)
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Event Date 05/12/2017 |
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.Medical devices: item # unk, stem, lot # unk, item # unk, head, lot # unk, item # unk, shell, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 05388, 0001825034 - 2018 - 05389, 0001825034 - 2018 - 05391.
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Event Description
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It was reported that approximately 4 weeks post implantation, the patient underwent an i&d due to non-healing wound.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This report is being submitted to relay additional information.Concomitant medical products: item # (b)(4), stem, lot # unk.
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Manufacturer Narrative
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This report is being submitted to relay additional information.Concomitant medical products: item # (b)(4), head, lot # unk.The following sections have been corrected: patient bmi.
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Manufacturer Narrative
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This report is being submitted to relay additional information.Concomitant medical products: (b)(4), taper sleeve, lot # unk.An additional report has been filed for this event.Please see associated report 0001825034-2018-08846.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.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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