MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 4 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	220220904
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Limb Fracture (4518)
Date of Event	01/22/2024
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 disposition unknown.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient underwent a revision procedure due to a peri prosthetic fracture.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient underwent a revision procedure due to a peri prosthetic fracture.
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 by healthcare professionals the following was observed "full tar (construct): there is a girdlestone situation visible in the upper ankle joint.A significant bone defect is present in the tibia as well as in the talus.There is also a consolidated supraarticular distal tibia fracture visible which is consolidated and addressed with a medial plate.Without any further information it can be assumed, that an infection took place and may have led to failure and the need to revise.As the time span between the fracture ((b)(6) 2023) and the infection is below 3 months, there is a chance, that the infection is due to the revision and implantation of the plate, however, it is not likely related to the implant.Therefore, the event is potentially user, but not device related." the failure is most likely caused by infection and bone defects in tibia and talus.However, 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.Furthermore, our healthcare professional opined that the time span between the fracture ((b)(6) 2023) and the infection is below 3 months, there is a chance, that the infection is due to the revision and implantation of the plate, however, it is not likely related to the implant.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INBONE TALAR DOME SZ 4 SULCUS
• 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: 18735802
• Report Number: 3010667733-2024-00086
• Device Sequence Number: 6276077
• Product Code: HSN
• UDI-Device Identifier: 00840420124234
• UDI-Public: 00840420124234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: 220220904
• Device Lot Number: 1727177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2022
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female