|
Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Information (3190)
|
Event Date 10/07/2011 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Medical product: unknown oss femoral component, catalog # unknown lot # unknown, unknown oss assembly catalog# unknown, lot # unknown, unknown oss stem, catalog # unknown lot # unknown, unknown oss stem, catalog # unknown lot # unknown, unknown oss tibial tray, catalog # unknown lot # unknown, unknown palacos bone cement : catalog # unknown lot # unknown.Initial reporter: ben molenaers, nele arnout, johan bellemans ¿complex total knee arthroplasty using resection prosthesis at mid-term follow-up¿ department of orthopaedics and traumatology ¿ the knee (2012) 550-554.(b)(4).The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05577, 0001825034-2017-05578, 0001825034-2017-05579, 0001825034-2017-05580, 0001825034-2017-05581.
|
|
Event Description
|
It was reported in a journal article that six (6) patients post operative final follow-up score was rated as poor.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Concomitant medical product: unknown oss femoral component, catalog # unknown lot # unknown ; unknown oss assembly catalog# unknown, lot # unknown ; unknown oss stem, catalog # unknown lot # unknown ; unknown oss stem, catalog # unknown lot # unknown ; unknown oss tibial tray, catalog # unknown lot # unknown ; unknown palacos bone cement : catalog # unknown lot # unknown ; unknown patella: catalog# unknown lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05577 , 0001825034-2017-05578 , 0001825034-2017-05579 , 0001825034-2017-05580 , 0001825034-2017-05581, 0001825034-2017-06798, 0001825034-2017-06798.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.
|
|
Manufacturer Narrative
|
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
|
|
Search Alerts/Recalls
|
|
|