MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE EVERLAST SZ 2 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	22022208
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient underwent a total ankle revision surgery.The poly that was removed had posterior wear on it.The tibial and talar components were intact so they were not replaced.The new poly that was opened would not fit into the inserter.The physician attempted to fit it into both the left and right inserters to make sure it wasn't an issue with the poly inserter itself, but it would not slide into either.Another poly of the same size was opened, and it fit in the inserter.
Event or Problem Description
It was reported that the patient underwent a total ankle revision surgery.The poly that was removed had posterior wear on it.The tibial and talar components were intact so they were not replaced.The new poly that was opened would not fit into the inserter.The physician attempted to fit it into both the left and right inserters to make sure it wasn't an issue with the poly inserter itself, but it would not slide into either.Another poly of the same size was opened, and it fit in the inserter.
Additional Manufacturer Narrative
Please disregard the mfr report # 3010667733-2024-00821.Please note that this event is duplicate of stryker report mfr.Report # 3010667733-2024-00819 stryker pi 3798813.

• Brand Name: INBONE EVERLAST SZ 2 8MM 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: 20605268
• Report Number: 3010667733-2024-00821
• Device Sequence Number: 7393137
• Product Code: HSN
• UDI-Device Identifier: 00889797074865
• UDI-Public: 00889797074865
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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 Catalogue Number: 22022208
• Device Lot Number: 1661093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 62 YR
• Patient Sex: Female