Model Number N/A |
Device Problems
Collapse (1099); Migration (4003)
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Patient Problem
No Code Available (3191)
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Event Date 08/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source - foreign: (b)(6).The complainant has not yet indicated whether 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.Insufficient information.
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Event Description
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It is reported that the patient is scheduled to undergo a knee arthroplasty revision to address loosening and collapse of an expandable compress device post-operatively, resulting in loss of leg length (approximately 2.5 centimeters).Attempts are currently being made to obtain additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not 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 further event information available at the time of this report.
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Search Alerts/Recalls
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