MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 4+ 7MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33685407

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

Patient Problems Discomfort (2330); Numbness (2415); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 08/08/2023

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.

Event Description

Clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): subject 600-008 as reported: "left ankle pain, swelling, and numbness patient was seen for 3 month follow up of left ankle on (b)(6) 2023 with complaints of pain, swelling, and numbness since last visit on (b)(6) 2023.Most of the pain was reported outside aspect of ankle.Examination showed well-healed scar with tenderness of left subtalar joint with minimal discomfort lateral aspect of the ankle.Radiographic imaging showed no evidence of lucency.Around the hardware.Patient is to continue wearing boot, physical therapy, use voltaren gel, and stabilize the ankle with prescribed lace-up ankle brace.".

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

Clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): subject (b)(6).As reported: "left ankle pain, swelling, and numbness patient was seen for 3 month follow up of left ankle on (b)(6) 2023 with complaints of pain, swelling, and numbness since last visit on (b)(6) 2023.Most of the pain was reported outside aspect of ankle.Examination showed well-healed scar with tenderness of left subtalar joint with minimal discomfort lateral aspect of the ankle.Radiographic imaging showed no evidence of lucency.Around the hardware.Patient is to continue wearing boot, physical therapy, use voltaren gel, and stabilize the ankle with prescribed lace-up ankle brace.".

• Brand Name: INFINITY EVERLAST SZ 4+ 7MM 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17865029
• MDR Text Key: 324866102
• Report Number: 3010667733-2023-00587
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797074636
• UDI-Public: 00889797074636
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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: 33685407
• Device Lot Number: 1716500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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: 50 YR
• Patient Weight: 100 KG