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

Catalog Number	33680034
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): subject: (b)(6).Implant subsidence.Patient underwent surgery on (b)(6) 2024, ankle tibiotalar calcaneal arthrodesis placement custom cage, allograft ankle hardware removal to address implant subsidence documented.".
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.
Event or Problem Description
As reported: "clinical study infinity¿ with adaptis¿ technology total ankle replacement follow-up (itar2): (b)(4).Implant subsidence.Patient underwent surgery on (b)(6) 2024, ankle tibiotalar calcaneal arthrodesis placement custom cage, allograft ankle hardware removal to address implant subsidence documented.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.Review of op.Report & other provided medical records were performed.Operative note and discharge summary was reviewed which confirms that there was no abnormality observed during or post surgery, everything went as planned, and there were no complications.The patient tolerated the procedure well and was sent to the recovery room in stable condition, and later patient was discharged after successful surgery.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: FLAT CUT TALAR DOME SZ 4 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: 21100513
• Report Number: 3010667733-2025-00013
• Device Sequence Number: 21066557
• Product Code: HSN
• UDI-Device Identifier: 00889797073080
• UDI-Public: 00889797073080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 33680034
• Device Lot Number: 1739353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2022
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 100 KG