MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ5 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33680005
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Inadequate Osseointegration (2646)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
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 on a supplemental report.H3 other text : device remains implanted.
Event or Problem Description
There is an upcoming revision surgery due to the loosening of the tibia tray.The surgeon would like to try and do another infinity tibia tray if possible in addition to a flat top talus.
Event or Problem Description
There is an upcoming revision surgery due to the loosening of the tibia tray.The surgeon would like to try and do another infinity tibia tray if possible in addition to a flat top talus.
Additional Manufacturer Narrative
Please note the correction regarding the d4 lot#: the reported event was confirmed based on available medical records and health care professional assessment the device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number communicated does not match with the database.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿the overall bone substance is very poor as it seems to be a posttraumatic implantation, where consolidation of the bone was achieved, but there are large cysts tibially and fusion between the distal tibia and fibula.Overall, there is not too much of radiolucence or cysts around the tibial component, but it seems to be loosened clinically according to the treating surgeons judgement.The pe cannot be assessed directly, but there are no signs of dislocation or fracture.The talar component has some radiolucence and small cysts, but there is no clear loosening and no migration visible.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused by poor bone quality and presence of cysts around tibia and fusion of distal tibia and fibula.Along with this small cyst around talar component contribute to failure of implant.If the device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY ADAPTIS TIB SZ5 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: 17085500
• Report Number: 3010667733-2023-00319
• Device Sequence Number: 14997725
• Product Code: HSN
• UDI-Device Identifier: 00889797069670
• UDI-Public: 00889797069670
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• 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): 10/20/2023

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 Model Number: 33680005
• Device Catalogue Number: 33680005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown