MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 3+ 7MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33684307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Fluid Discharge (2686)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
It was reported that the patient presented 6 weeks post procedure with mrsa infection.The physician explanted all implants and implanted a cement spacer.
Event or Problem Description
It was reported that the patient presented 6 weeks post procedure with mrsa infection.The patient had about one month with wound dehiscence that chronically didn't heal that eventually had pseudomonas that got long term antibiotics.The physician explanted all implants and implanted a cement spacer.When the physician initially saw the patient they presented with huge anterior wound and a posteromedial draining sinus.On the ensuing days after explant patient seeded left artificial knee and left native ankle.The physician says that he went back to operating room a couple more times (didn't state procedures).The physician states the physician is healing appropriately now and doing fine.The surgeon states roughly two to three months and they will revise with invision total ankle.
Additional Manufacturer Narrative
The reported event could be confirmed, based on available medical record and information provided in complaint.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.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing surgeon¿s feedback and sterility test reports we can conclude that patient is suffering from bacterial infection caused by psuedomonas and mrsa.Also, a huge anterior wound and a posteromedial draining sinus was observed in patient.After device explant couple of procedures were performed and finally surgeon confirmed that patient is healing and doing well.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention and the aftercare.Also, we could not find any non conformance associated with sterilization.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.However, bacterial infection is confirmed at anterior wound.If the device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY EVERLAST SZ 3+ 7MM TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17599444
• Report Number: 3010667733-2023-00471
• Device Sequence Number: 12603800
• Product Code: HSN
• UDI-Device Identifier: 00889797074551
• UDI-Public: 00889797074551
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33684307
• Device Lot Number: 1735026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male