MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 4+ 7MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33655407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.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.
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
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual examination of the returned poly finds the removal tool still remains inside the poly.It appears the tool has been cut.There is damage to the lock detail consistent with removal techniques.The dovetail feature also has bilateral damage.Visual examination of the articulating surface of the poly finds wear consistent with contact with the talar dome.Visual examination of the talar dome finds scratches and evidence of articulation with the poly.There is evidence of bone cement around one of the pegs.There are also chisel marks on the peg with the bone cement and in multiple locations on the inferior side of the talar dome, consistent with damage caused during removal.Visual examination of the tibial tray finds most of the superior side covered with bone cement.There are chisel marks on all three pegs and scratches on the anterior side which are consistent with damaged caused during removal.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 user that: ¿improper selection, placement, positioning, and fixation of the prosthetic components may result in unusual stress conditions and a subsequent reduction in service life of the prosthetic component.Periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.¿ formal medical opinion was sought from an experienced independent medical expert as below: ¿the prophecy report on case 63581 clearly shows subsidence of the talar component indicating loosening.It looks like the primary implantation of the infinity tar was done well.The amount of subsidence/loosening justifies a revision to prevent unnecessary further bone loss and deformation of the tibia, from an orthopedic surgical standpoint of view.I have no information to make such an assessment from a medical point of view.Without any further clinical information, i cannot assess any medical factors any further.¿ more detailed information about the complaint event such as clinical information must be available to determine the root cause of the complaint event.If any further information is provided, the complaint report will be updated.

• Brand Name: INFINITY POLY SZ 4+ 7MM 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: 13862012
• Report Number: 3010667733-2022-00131
• Device Sequence Number: 4666032
• Product Code: HSN
• UDI-Device Identifier: 00840420122827
• UDI-Public: 00840420122827
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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 Expiration Date: 05/22/2025
• Device Model Number: 33655407
• Device Catalogue Number: 33655407
• Device Lot Number: 1592306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2017
• 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: Required Intervention
• Patient Sex: Unknown