Model Number N/A |
Device Problem
Unintended System Motion (1430)
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Patient Problems
Pain (1994); Limited Mobility Of The Implanted Joint (2671)
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Event Date 01/04/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 00434901013 humeral stem 10 mm stem diameter 130 mm stem length 62790792, 00434903600 poly liner plus 0 mm 62890669, 00434901500 base plate 15 mm post length uncemented 63035360.The complaint is under investigation.Once the investigation is complete a follow mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 06719, 0001822565 - 2018 - 06722, 0001822565 - 2018 - 06727.
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Event Description
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It was reported in a clinical study that the patient underwent initial left reverse shoulder arthroplasty and was subsequently experiencing ongoing pain, impingement at one and two year time frame follow-ups.Limited range of motion and worsening pain were noted at three year time frame follow-up.No medical intervention was required.No additional information is available at this time.
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Manufacturer Narrative
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The complaint was confirmed based on the clinical documents.Device history records were reviewed and no deviations and/ or anomalies relevant to the reported event were found.A definite root cause cannot be determined with the information 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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No additional information is available to report at this time.
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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 follow report is submitted to relay additional information received: report source: foreign- united kingdom.The complaint is under investigation.Once the investigation is completed a follow up report will be submitted.
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Search Alerts/Recalls
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