Model Number N/A |
Device Problem
Difficult To Position (1467)
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Patient Problem
No Information (3190)
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Event Date 03/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001825034-2018-02955.Concomitant medical products: bio-modular shoulder humeral stem pn113705 ln1354256.Foreign report source- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 the patient underwent a conversion of a hemi shoulder to a reversed shoulder.During the procedure, it was observed that the conversion humeral tray would not fit the humeral stem.The surgeon removed the stem and implanted a different one.The required intervention created a surgical delay greater than two hours.No further information was available.
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Manufacturer Narrative
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(b)(4).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.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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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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