|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Swelling/ Edema (4577)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-02525, 0001825034-2021-02526, and 0001825034-2021-02527.Medical devices: vanguard cr ilok fem-rt 67.5 catalog#: 183010 lot#: 146930.Biomet cc cruciate tray 75mm catalog#: 141234 lot#: 620910.E1 vngd as tib brg 12x75 catalog#: ep-189082 lot#: 505570.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that patient is being undergoing physical therapy approximately eleven years post implantation to deal with pain and swelling.Attempts to obtain additional information have been made; however, no more is available.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.Swelling has been confirmed by physical therapy notes and x-ray review.However, pain cannot be confirmed.Review of the physical therapy notes found pain after walking more than a mile and swelling with strenuous activity.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|