MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680033
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Limb Fracture (4518); Swelling/ Edema (4577)
Date of Event	11/07/2023
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.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that the during the six 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.It was reported that the patient presented to the emergency department on (b)(6) 2023 due to presence of atrial fibrillation during preoperative workup for left ankle revision surgery.The patient was admitted to the hospital for observation.
Additional Manufacturer Narrative
Please disregard the mfr report # 3010667733-2023-00796 as per further confirmation this event was found to be a duplicate of the mfr.Report # 3010667733-2023-00581.
Event or Problem Description
It was reported that the during the six 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.It was reported that the patient presented to the emergency department on (b)(6) 2023 due to presence of atrial fibrillation during preoperative workup for left ankle revision surgery.The patient was admitted to the hospital for observation.

• Brand Name: FLAT CUT TALAR DOME SZ 3 INFINITY ADAPTIS
• 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: 18360458
• Report Number: 3010667733-2023-00796
• Device Sequence Number: 18085554
• Product Code: HSN
• UDI-Device Identifier: 00889797073073
• UDI-Public: 00889797073073
• Combination Product (Y/N): N
• 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: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 33680033
• Device Lot Number: 1732184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Male