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

Model Number	33654408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complains of right ankle pain and swelling.He has pain with increased walking.He has pain both medially and laterally.The patient has failed conservative measures and would benefit from surgical intervention.The patient underwent a revision surgery approximately 31 months after initial surgery.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since operative notes were provided for evaluation and match to the alleged failure mode.A device inspection was not possible since the affected device was not returned, and no other evidence was provided 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.The instructions for use instructs the user that: ¿periodic post-operative x-rays are recommended for close comparison with early post-op conditions to detect long term evidence of changes in position, loosening, bending, or cracking of components.¿ strictly based on the operative notes received, a formal medical opinion was requested from an independent healthcare expert.In this patient with good bone quality, aseptic loosening can be suggested (no preoperative suspicion mentioned, and no cultures taken intra-operatively).Nevertheless, a low-grade infection cannot be ruled out with certainty.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event if any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient complains of right ankle pain and swelling.He has pain with increased walking.He has pain both medially and laterally.The patient has failed conservative measures and would benefit from surgical intervention.The patient underwent a revision surgery approximately 31 months after initial surgery.

• 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: 13044395
• Report Number: 3010667733-2021-00020
• Device Sequence Number: 5409970
• Product Code: HSN
• UDI-Device Identifier: 00840420122797
• UDI-Public: 00840420122797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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 Model Number: 33654408
• Device Catalogue Number: 33654408
• Device Lot Number: 1636259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 109 KG