MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680014

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Synovitis (2094); Implant Pain (4561)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

The complaint was confirmed, since the information for evaluation matches the alleged failure.The investigation revealed the following: review of information received: based on the received information it is likely that the patient suffered pain, as voltaren gel got prescribed to use.In regard to this information the complaint is confirmed, but otherwise no other statement can be made, as no imaging material was submitted.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.H3 other text : the product is not available for return.

Event Description

The patient, who underwent an infinity¿ with adaptis¿ technology total ankle replacement, reported stiffness and medial pain in the ankle during a clinic visit.Relief was found from a previous gutter debridement procedure, but medial pain persisted, exacerbated by activity.Swelling was relieved with rest and elevation.Spect ct scan showed increased uptake along the medial ankle and talus, but no implant loosening was found.Treatment included continuation of a home exercise program and prescribed voltaren gel, with consideration of future medial gutter debridement and placement of a medial ossio screw.An update indicated that the patient underwent a planned outpatient procedure, including ankle open reduction internal fixation medial malleolus with excision of medial lateral spurs, gutter debridement, and right ankle synovectomy, addressing the previously reported adverse events.Further details were pending completion and signing of the operative note.It was noted that the patient had undergone the outpatient procedure to address the adverse events mentioned earlier.

• Brand Name: INFINITY ADAPTIS TIB SZ4LNG 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: 19105604
• MDR Text Key: 340156792
• Report Number: 3010667733-2024-00213
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: 00889797069694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2024

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: 33680014
• Device Lot Number: 1737410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2022
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 90 KG