MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 1 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33650001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient may need to undergo a revision surgery due to increased pain and swelling 6- 8 months post-op.The patient's infection work up has been negative.
Additional Manufacturer Narrative
Device is not available for return as it remains implanted in the patient.When additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence 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.Upon further investigation of the ct scans, healthcare professionals opined that- ¿there is failure confirmed with the surgeon's assessment.Infection was considered as a potential underlying cause.The ct scan shows some radiolucence and small cysts.Loosening of the tibia is likely.There is no clear sign of migration.The talus looks unsuspicious.No comment can be given regarding the underlying cause.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 or Problem Description
It was reported that the patient may need to undergo a revision surgery due to increased pain and swelling 6- 8 months post-op.The patient's infection work up has been negative.

• Brand Name: INFINITY TIBIAL TRAY SIZE 1 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: 19636342
• Report Number: 3010667733-2024-00407
• Device Sequence Number: 8610783
• Product Code: HSN
• UDI-Device Identifier: 00840420122483
• UDI-Public: 00840420122483
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: 33650001
• Device Lot Number: 1699805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2021
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Unknown