Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Cyst(s) (1800)
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Event Date 02/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, remains implanted.The investigation is in process.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: 0001825034-2019-01066.
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Event Description
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It was reported that the patient had underwent a open rotator cuff repair with subacromial debridement on the right shoulder, and subsequently the patient experienced cystic changes approximately six (6) years post implantation.No additional information is available.
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Event Description
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No additional information is available to report at this time.
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Manufacturer Narrative
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The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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The following report is being submitted to report additional information received: the reported event is confirmed based on the operative records that were provided stating per radiology report the lack of contrast media, the slightly sclerotic limiting the cyst and the association with the suture anchor is may be due to cystic changes / ganglia due to the suture anchors.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause could not be determined.It is noted that the patient experienced a trauma to the shoulder which may have been a contributing factor.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information is available to report at this time.
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Search Alerts/Recalls
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