MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 2 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33650002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Ambulation or Postural Difficulties (2544); Renal Impairment (4499); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "hospitalization due to pain in right ankle.Right ankle pain and inability to weight bear.Right ankle swollen and hot to touch.Diagnosed with gout arthritis and commenced on colchicine and analgesia.Confused in hospital inr found to be elevated and in renal failure.Rivaroxiban suspended until renal function improves.".
Event or Problem Description
As reported: "hospitalization due to pain in right ankle.Right ankle pain and inability to weight bear.Right ankle swollen and hot to touch.Diagnosed with gout arthritis and commenced on colchicine and analgesia.Confused in hospital inr found to be elevated and in renal failure.Rivaroxiban suspended until renal function improves".
Additional Manufacturer Narrative
The complaint could be confirmed, since the information for evaluation matches the alleged failure.Investigator reviewed the received information and noted: hospitalization due to pain in right ankle.Inability to weight bear.Right ankle swollen and hot to touch.Diagnosed with gout arthritis and commenced on colchicine and analgesia.Based to the reporter this is not due to product problem.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INFINITY TIBIAL TRAY SIZE 2 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19404037
• Report Number: 3010667733-2024-00319
• Device Sequence Number: 15192406
• Product Code: HSN
• UDI-Device Identifier: 00840420122490
• UDI-Public: 00840420122490
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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 Expiration Date: 11/10/2025
• Device Catalogue Number: 33650002
• Device Lot Number: 1610086
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2017
• 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: Other
• Patient Sex: Female