(b)(4).
Reported event was unable to be confirmed as part number and lot number of the device involved in the incident is unknown.
Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.
Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.
There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.
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.
This report is being submitted late as it has been identified in remediation.
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, cresswell, t.
, espag, m.
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(2014).
Medium-term clinical results of a linked total elbow replacement system.
Bone & joint journal, 96-b(10), 1359-1365.
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96b10.
33815.
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