MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33653306
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement surgery.Approximately 6 months post-op the patient experienced pain and was evaluated for infection and stabilized at 1 year post-op.Approximately 2 years post-op had swelling and pain.The surgeon stated that he had recommended surgery before but due to the patients unstable mental status the patient elected not to agree to the surgery.32 months post-op the patient underwent a revision in which the implants were removed and a fusion procedure was performed.Surgeon reported isolated staph capitus from several samples taken at the time of revision.

• Brand Name: INFINITY¿ 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12883155
• Report Number: 0001043534-2021-00234
• Device Sequence Number: 4802708
• Product Code: HSN
• UDI-Device Identifier: 00840420122704
• UDI-Public: 00840420122704
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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 Expiration Date: 12/16/2025
• Device Model Number: 33653306
• Device Catalogue Number: 33653306
• Device Lot Number: 1605286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 89 KG