MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680032
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/19/2024
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
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to pain in the ankle.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to pain in the ankle.
Additional Manufacturer Narrative
Correction - h6(device code).The reported event could be confirmed based on available medical record and medical expert assessment.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.Failure of total ankle replacement (tar) over time is a known complication.In case of a planned revision procedure a medical opinion is part of the internal investigation process.Sufficient (radiological and clinical) information must be provided to enable a proper full clinical assessment and to identify possible causes of failure.In cases where a ct scan is the only available clinical source the informative value and the assessment of the underlying potential cause of a failure is severely limited.In the vast majority of these cases no conclusive statement can be provided, because the accompanying clinical information (e.G.Clinical status, exact symptoms and range of motion of the patient) is missing.Radiographic findings such as radiolucent areas and bone cysts may indicate potential problems, but their clinical significance remains uncertain without the additional context.Due to the limited information and clinical context, we therefore refrain from making definitive statements about the patient, the procedure and/or the device in relation to the failure.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿there is radiolucence and subsidence visible in the talus.The implants are loosened and migrated.Due to a lack of clinical information an assessment regarding the underlying cause is limited.¿ 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.According to the hcp¿s assessment there is radiolucency and subsidence visible in the talus and the tibia and hence loosening and migration can be confirmed, but due to a lack of clinical information an assessment regarding the underlying cause is limited.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: FLAT CUT TALAR DOME SZ 2 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: 19102771
• Report Number: 3010667733-2024-00211
• Device Sequence Number: 15289608
• Product Code: HSN
• UDI-Device Identifier: 00889797073066
• UDI-Public: 00889797073066
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 33680032
• Device Lot Number: 1728380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/18/2024
• Initial Report FDA Received Date: 04/13/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2022
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Male