MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY EVERLAST SZ 3+ 9MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33684309
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Swelling/ Edema (4577)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
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.H3 other text : device disposition unknown.
Event or Problem Description
Clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): subject (b)(6).As reported: "facture lines under talus prosthesis with loss of talar height.During 6 month follow up visit (b)(6) 2023, evidence of talus subsidence was documented in radiographic follow-up and ct was requested.The ct of the left ankle performed on (b)(6) 2023 was reviewed with patient on (b)(6) 2023 with findings of fracture lines under the talus prosthesis with loss of talar height.Physical examination showed mild left ankle tenderness to palpitation and moderate swelling.Surgical intervention was recommended due to failed conservative measures.Patient will require revision total ankle replacement with custom talar component due to talus fracture loss of height.".
Event or Problem Description
Clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): subject (b)(6).As reported: "fracture lines under talus prosthesis with loss of talar height during 6 month follow up visit (b)(6) 2023, evidence of talus subsidence was documented in radiographic follow-up and ct was requested.The ct of the left ankle performed on (b)(6) 2023 was reviewed with patient on (b)(6) 2023 with findings of fracture lines under the talus prosthesis with loss of talar height.Physical examination showed mild left ankle tenderness to palpitation and moderate swelling.Surgical intervention was recommended due to failed conservative measures.Patient will require revision total ankle replacement with custom talar component due to talus fracture loss of height.".
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INFINITY EVERLAST SZ 3+ 9MM 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17861147
• Report Number: 3010667733-2023-00582
• Device Sequence Number: 14935014
• Product Code: HSN
• UDI-Device Identifier: 00889797074568
• UDI-Public: 00889797074568
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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: 33684309
• Device Lot Number: 1730909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 141 KG