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

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518); Swelling/ Edema (4577)

Event Date 11/07/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 330934155
• Report Number: 3010667733-2023-00796
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33680033
• Device Lot Number: 1732184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male