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

Model Number	33684307
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in the patient.
Event or Problem Description
At their 6 month follow up on (b)(6) 2023, the patient complained of ankle swelling, pain, and stiffness.The pi recommended the patient undergo right ankle debridement.Patient agreed and the procedure was scheduled for (b)(6) 2023.During the procedure the medial lateral gutters were cleared out of any spurs and bone.Patient was discharged on the same day.
Additional Manufacturer Narrative
The complaint was confirmed, since the information received confirm that the patient got additional treatment.A device inspection was not possible since the affected device was not returned for investigation.Cutout of the reporting from surgeon "patient who had a previous total ankle replacement.He has good position of the hardware.He had a posttraumatic injury and has stiffness of the ankle.He has some residual pain.He has medial and lateral gutter impingement.For that reason, further surgery is indicated." 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.Based on investigation, the root cause was attributed to a patient factors issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
At their 6 month follow up on 27-mar-2023, the patient complained of ankle swelling, pain, and stiffness.The pi recommended the patient undergo right ankle debridement.Patient agreed and the procedure was scheduled for (b)(6) 2023.During the procedure the medial lateral gutters were cleared out of any spurs and bone.Patient was discharged on the same day.

• 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: 17062425
• Report Number: 3010667733-2023-00315
• Device Sequence Number: 18286928
• Product Code: HSN
• UDI-Device Identifier: 00889797074551
• UDI-Public: 00889797074551
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 33684307
• Device Catalogue Number: 33684307
• Device Lot Number: 1719138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 90 KG