MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 1/1+ 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33681108

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Post Operative Wound Infection (2446); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 08/03/2023

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 disposition unknown.

Event Description

It was reported that the patient presented to the clinic on (b)(6) 2023 with the complaint of increased pain and swelling in ankle following the use of dynasplint for 2 days.Additionally, there was purulent drainage coming from the patient's anterior ankle wound and surrounding erythema.There is obvious opening of the surgical wound and suspected deep infection.The patient needs to return to or for i&d and poly exchange.The patient was given medications and underwent a revision surgery of the polyethylene insert on (b)(6) 2023.

Manufacturer Narrative

The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.Microbiologist reviewed the sterility of the dhr and noted: the subject device was packaged according to established design and process specifications, and got sterilized through gamma radiation.No deviation for a non-conformance could be found.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.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient presented to the clinic on (b)(6) 2023 with the complaint of increased pain and swelling in ankle following the use of dynasplint for 2 days.Additionally, there was purulent drainage coming from the patient's anterior ankle wound and surrounding erythema.There is obvious opening of the surgical wound and suspected deep infection.The patient needs to return to or for i&d and poly exchange.The patient was given medications and underwent a revision surgery of the polyethylene insert on (b)(6) 2023.

• Brand Name: INFINITY EVERLAST SZ 1/1+ 8MM TOTAL ANKLE SYSTEM
• Type of Device: 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: 17725938
• MDR Text Key: 323149890
• Report Number: 3010667733-2023-00524
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797074360
• UDI-Public: 00889797074360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33681108
• Device Lot Number: 1753963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 86 KG