MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	200009901
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not available.
Event or Problem Description
It was reported that the patient underwent a total ankle surgical procedure.Allegedly, the base stem was dropped on the floor and the hospital would not process due to the ifu instructions.This was the only 16mm base stem in the kit, as only one of this size is standard in the kit.The 18mm stem would not fit on the tibia tray that was needed, so there was no back up available.A cement spacer was put into the joint space and the patient had to undergo a second surgical procedure the following day.
Additional Manufacturer Narrative
The reported event could be not confirmed, since the product was not returned.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.
Event or Problem Description
It was reported that the patient underwent a total ankle surgical procedure.Allegedly, the base stem was dropped on the floor and the hospital would not process due to the ifu instructions.This was the only 16mm base stem in the kit, as only one of this size is standard in the kit.The 18mm stem would not fit on the tibia tray that was needed, so there was no back up available.A cement spacer was put into the joint space and the patient had to undergo a second surgical procedure the following day.

• Brand Name: INFINITY TOTAL ANKLE SYSTEM
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 12193508
• Report Number: 0001043534-2021-00122
• Device Sequence Number: 1323455
• Product Code: HSN
• UDI-Device Identifier: 00840420123831
• UDI-Public: 00840420123831
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: Health Professional
• Device Model Number: 200009901
• Device Catalogue Number: 200009901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention