MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. FLAT CUT TALAR DOME SZ 4 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680034
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Swelling/ Edema (4577)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "subject: (b)(6) infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2) patient presented to the clinic for a postop follow up appointment on (b)(6) 2022 (3 months s/p left tar procedure), concerned about continued significant swelling and discomfort.The surgeon ordered an ultrasound to rule out a left lower extremity deep vein thrombosis (dvt) on (b)(6) 2022.Ultrasound report found no evidence of a dvt.Patient is scheduled for another postop visit on (b)(6) 2022 (6 months s/p left tar procedure).Update 08 dec 2022: patient reported swelling has improved.".
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 in a supplemental report.
Event or Problem Description
As reported: "subject: (b)(6) infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2).Patient presented to the clinic for a postop follow up appointment on (b)(6) 2022 (3 months s/p left tar procedure), concerned about continued significant swelling and discomfort.The surgeon ordered an ultrasound to rule out a left lower extremity deep vein thrombosis (dvt) on (b)(6) 2022.Ultrasound report found no evidence of a dvt.Patient is scheduled for another postop visit on (b)(6) 2022 (6 months s/p left tar procedure).Update on (b)(6) 2022: patient reported swelling has improved.".
Additional Manufacturer Narrative
The reported event could not be confirmed based on available information.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.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.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: FLAT CUT TALAR DOME SZ 4 INFINITY ADAPTIS
• Common Device Name: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• 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: 20307752
• Report Number: 3010667733-2024-00640
• Device Sequence Number: 15401622
• Product Code: HSN
• UDI-Device Identifier: 00889797073080
• UDI-Public: 00889797073080
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 33680034
• Device Lot Number: 1724386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2022
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 98 KG