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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Date 06/25/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event.Please see associated reports: 0001825034 - 2018 - 01428; 0001825034 - 2018 - 01427.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.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.Device remains implanted.
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Event Description
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It was reported in clinical study (b)(6) the patient had severe pain, difficulty ambulating, loss of range of motion, and difficulty sleeping post-operatively.Attempts have been made and no further information has been made available at this time.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.Please void this submission.
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Search Alerts/Recalls
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