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	Implant Pain (4561)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision surgery due to persistent pain.The surgeon decided to do a gutter debridement procedure, which required removal of the poly insert to obtain visually and get to the area.There was no problem with the poly or tar, just moved out of the way.It was an incidental removal required to proceed and a new poly insert was replaced.The tibia and talus implant remain from primary tar.
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 on a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to persistent pain.The surgeon decided to do a gutter debridement procedure, which required removal of the poly insert to obtain visually and get to the area.There was no problem with the poly or tar, just moved out of the way.It was an incidental removal required to proceed and a new poly insert was replaced.The tibia and talus implant remain from primary tar.
Additional Manufacturer Narrative
Correction - h6 (method, results & conclusion codes).The reported event could be confirmed, based on the information provided by clinical team.The device inspection was not possible as the product was not returned 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.Based on investigation, the root cause was attributed to a user related issue, as communicated that the nature of this complaint is to only report a poly exchange for surgical visual access and no product complaint really.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: 15341292
• Report Number: 3010667733-2022-00294
• Device Sequence Number: 20139115
• Product Code: HSN
• UDI-Device Identifier: 00840420122827
• UDI-Public: 00840420122827
• 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: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 33655407
• Device Catalogue Number: 33655407
• Device Lot Number: 1628889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2018
• 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: Required Intervention
• Patient Sex: Unknown