ZIMMER, INC. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) LEFT 14 MM HEIGHT; PROSTHESIS, KNEE
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Rash (2033)
|
Event Date 07/05/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.This report is number 4 of 5 mdrs filed for the same patient (reference 3007963827-2017-00002 , 0002648920-2017-00027, 3007963827-2017-00003, 0001822565-2017-00307, & 0001822565-2017-00310).
|
|
Event Description
|
Patient alleged experiencing left knee rash approximately five months post-implantation.No additional information provided.
|
|
Manufacturer Narrative
|
Event date is unknown.Concomitant medical products- all poly patella cemented # 42540000029 lot # 63339813, femur cemented cruciate retaining (cr) narrow left # 42502006401 lot # 63092440, tibia cemented 5 degree stemmed left # 42532007101 lot # 63347843, palacos r 1x40 single # 00111214001 lot # 80364394.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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.
|
|
Search Alerts/Recalls
|
|
|