MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TALDOME SZ1 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680021
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient require a revision surgery of the tibial and talar components.The surgery won't be done until at least february.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided 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 require a revision surgery of the tibial and talar components.The surgery won't be done until at least february.
Additional Manufacturer Narrative
Please note correction to h6 (device and health impact codes).The reported event could be confirmed since images of ct scans were provided and shows loosening of the talar component.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the talus shows some radiolucence as well, anteriorly and a little bit around the pegs.Loosening is likely, there is no clear sign of migration.¿ based on investigation, the root cause was attributed to a patient related issue.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INFINITY ADAPTIS TALDOME SZ1 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; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18414207
• Report Number: 3010667733-2023-00816
• Device Sequence Number: 2748446
• Product Code: HSN
• UDI-Device Identifier: 00889797101516
• UDI-Public: 00889797101516
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K172633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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: 33680021
• Device Lot Number: 1697734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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 Sex: Female