MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TALAR DOME SZ 5 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33630025
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: patient requires revision surgery due to pain and loosening of the tibia and talus components.
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported: patient requires revision surgery due to pain and loosening of the tibia and talus components.Additional information received indicates: plan is for full revision of all implants.Will use invision the reported pain and loosening of tibia and talus components likely due to increased stress with subtalar fusion and sclerotic distal tibia from prior fracture and surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.Upon further investigation of the ct scans, healthcare professionals opined that: ¿loosening and subsidence of tibial component, some subsidence of talar component.No clinical information available.In cases where a ct scan is the only available clinical source, this assessment is limited.No conclusive statement can be provided, because key clinical information (e.G.Clinical status, exact symptoms and range of motion of the patient, assessment of the treating physician) is missing.The root causes of radiographic findings such as radiolucent areas and bone cysts are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure and/or the device in relation to cause of the failure".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: INFINITY TALAR DOME SZ 5 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.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19777526
• Report Number: 3010667733-2024-00448
• Device Sequence Number: 12779533
• Product Code: HSN
• UDI-Device Identifier: 00840420122063
• UDI-Public: (01)00840420122063(11)220307(17)300307(10)1722391
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K123954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33630025
• Device Lot Number: 1722391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2022
• 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: Other; Required Intervention
• Patient Sex: Unknown