MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 3 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33653306
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2022
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.The physician plans on cleaning out the gutters and swapping out the poly.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.The physician plans on cleaning out the gutters and swapping out the poly.Allegedly, the patient may need to undergo a revision surgery for reasons that are not available at the time of this report.New information received states that the patient underwent the surgery for poly swap.There was no implant loosening.No surgery delay was reported.No additional patient adverse consequences reported.
Additional Manufacturer Narrative
Correction - please refer to d1, h6 device code.The reported event could not be confirmed due to lack of additional information.A medical professional reviewed the received information and noted the following: ¿from what can be seen in the ct-scan not much more information can be detected regarding this case.As the poly is not directly visible, the ct-scan only gives indirect information about the polys condition.While the anterior and central sections of the implant in the talus and tibia look inconspicuous, some translucent areas suggesting loosening in the posterior section cannot be excluded.However, this could be an artefact and the surgeon¿s assumption, that neither the tibial nor the talar component are loosened seemed to be correct.The ct scan does not allow any other reliable interpretation.¿ 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 was not possible because the lot number was not communicated.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.

• Brand Name: INFINITY POLY SZ 3 6MM 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: 15911300
• Report Number: 3010667733-2022-00423
• Device Sequence Number: 2492609
• Product Code: HSN
• UDI-Device Identifier: 00840420122704
• UDI-Public: 00840420122704
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 02/24/2023

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 Model Number: 33653306
• Device Catalogue Number: 33653306
• Device Lot Number: UNKNOWN
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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