Model Number N/A |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
No Code Available (3191)
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Event Date 11/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign- (b)(6).The complaint is under investigation.Once the investigation is completed a follow up mdr will be submitted.
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Event Description
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It was reported that during a revision of failed shoulder arthroplasty, it was determined that the broach was shorter than the humeral stem implant.The implant was not able to seat fully.An undersized implant was used with cement to complete the procedure.No impact to the surgery or patient was noted.No additional information is available.
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Event Description
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No additional information is available to 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.Dhr was unable to be reviewed, as lot number of the broach was not provided.A definite root cause cannot be determined with the information provided.A summary of the investigation has been sent to the complainant.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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