WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 1/1+ 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Catalog Number 33681108 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Impaired Healing (2378); Post Operative Wound Infection (2446)
|
Event Date 08/29/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.
|
|
Event Description
|
It was reported that the patient had delayed wound healing at anterior ankle incision.Treatment includes oral antibiotics and keeping incision covered and dry.On (b)(6) 2023, there was slight improvement of the incision since previous visit, however, delayed healing was still present.On (b)(6) 2023, it was noted that there was delayed wound healing improving with outpatient wound care.
|
|
Manufacturer Narrative
|
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
|
|
Event Description
|
It was reported that the patient had delayed wound healing at anterior ankle incision.Treatment includes oral antibiotics and keeping incision covered and dry.On (b)(6) 2023, there was slight improvement of the incision since previous visit, however, delayed healing was still present.On (b)(6) 2023, it was noted that there was delayed wound healing improving with outpatient wound care.
|
|
Search Alerts/Recalls
|
|
|