MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SZ 5 LNG TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33650015
Medical Device Problem Codes	Loss of Osseointegration (2408); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651); Insufficient Information (4580)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.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.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.
Additional Manufacturer Narrative
Correction - h6 (device, method, results, and clinical code).The reported event could be confirmed since images of ct scans were provided and matches the alleged failure mode.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.A medical professional reviewed the received information and noted the following: ¿the revised primary planning showed a bone void in the distal tibia.The ct-scan of the revision planning shows a bone void in the central distal part of the tibia, adjacent to the tibial component, including the posterior peg.This is not fixed to the bone anymore.Furthermore, there¿s a radiolucent line between the tibial implant and the bone, suspect of beginning of loosening.The anterior pegs, however, are still fixed to the bone.The pe-liner looks intact, as far as i can tell on a ct-scan.The retrieval is needed for a definitive assessment.The talar component is intact and well-fixed to the bone.It has subsided slightly anteriorly and there is osteopenia of the talus.The reason for revision most likely is the beginning of the tibial component loosening and the bone void.Clinical information is needed to make a definitive assessment (pain, joint motion, infection and more).¿ 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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for tibial component loosening and there were possible cystic changes.

• Brand Name: INFINITY TIBIAL TRAY SZ 5 LNG 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: 15807678
• Report Number: 3010667733-2022-00387
• Device Sequence Number: 5616546
• Product Code: HSN
• UDI-Device Identifier: 00840420122568
• UDI-Public: 00840420122568
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 06/30/2023
• Device Model Number: 33650015
• Device Catalogue Number: 33650015
• Device Lot Number: 1559199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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 Sex: Unknown