Catalog Number 00830002300 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Impaired Healing (2378); Post Operative Wound Infection (2446); No Code Available (3191)
|
Event Date 08/05/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
This report will be amended when our investigation is complete.
|
|
Event Description
|
It is reported the patient had a re-operation due to experiencing a delayed healing following implantation of an ankle prosthesis.
|
|
Manufacturer Narrative
|
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No device or photos were received; therefore the condition of the device is unknown.Design history records review indicates that all devices were manufactured to specifications for tibial base, talar component and tibial insert.This device used for treatment.An initial product history search was conducted and revealed no additional complaints against the related part and lot combination for tibial, talar or tibial insert.A definite root cause cannot be determined with the information provided.
|
|
Manufacturer Narrative
|
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 2 of 3 mdrs filed for the same patient (reference 1822565-2016-03369 / 03372).The patient's reoperation discharge summary was reviewed.The discharge summary states intraoperative cultures found staphylococcus epidermidis.This information does not change the root cause of the investigation previously reported.
|
|
Event Description
|
Patient underwent an irrigation and debridement procedure, hardware removal, and re-fixation of the ankle approximately two months following a total ankle arthroplasty due to delayed wound healing and wound breakdown.The patient was additionally administered a pic line four days following re-operation.
|
|
Search Alerts/Recalls
|