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

Catalog Number	33680023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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.
Event or Problem Description
It was reported that the patient had and infinity system implanted.The ankle area became infected.The physician performed a wash out and poly swap.Allegedly, the patient may need to undergo a revision surgery for infection.No additional information is available.
Event or Problem Description
It was reported that the patient had and infinity system implanted.The ankle area became infected.The physician performed a wash out and poly swap.Allegedly, the patient may need to undergo a revision surgery for infection.No additional information is available.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.However, it was noted that the patient went into the ocean shortly after the primary surgery, before the wound had completely healed.Based on the information provided and the results of the investigation, the root cause was attributed to a patient related issue.The infection was caused by the patient swimming in the ocean prior to the surgical wound completely healing.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.If more information is provided, the case will be reassessed.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13485405
• Report Number: 3010667733-2022-00046
• Device Sequence Number: 12103360
• Product Code: HSN
• UDI-Device Identifier: 00889797101547
• UDI-Public: 00889797101547
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K172633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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: 33680023
• Device Lot Number: 1704500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 05/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female