Catalog Number 00430204627 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
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Event Description
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It was reported the patient had post operative pain in conjunction with pain and alleges developing crps and sjorgens disease within three weeks post primary left shoulder in 2016.No further information is available.
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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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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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Event Description
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It was reported that patient underwent left shoulder arthroplasty (b)(6) 2017 and subsequently is experiencing pain and alleges developing crps and sjorgens disease within three weeks of the procedure.The patient has not been revised and is requesting material composition of the implanted devices.No further information is available at the time of this reporting.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: primary di 00-4302-046-27 lot 62433463 bf offset hum head 27mm x 46mm 00889024265721, 00-4302-040-46 lot 63344409 bf 40mm pegged glenoid w/46mm 00889024265646 , 00-4342-110-13 lot 62867558 tm humeral stem 42 deg 00889024268630 .Multiple mdr's were filed for this event.Please see 0001822565 - 2019 - 01255, 0001822565 - 2019 - 02821, 0001822565 - 2019 - 02823.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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No further information available at the time of this reporting.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No device was returned.Medical record were reviewed but was unable to confirm the report.Device history record (dhr) review was performed with no related manufacturing deviations or anomalies identified.Root cause is unknown.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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