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

Catalog Number	33680001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Burning Sensation (2146); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.The information in this report was provided via a medwatch submitted by the user on medwatch # mw5161283.
Event or Problem Description
Reporter called to inform the fda that a stryker right ankle implant that she received in 2022 has failed.Implant failure was confirmed with a computed tomography (ct) where, the device has been shown to have separated and come apart.Reporter stated that since having the implant, she has been very sick and believes she may be having a reaction to the implant.Presently, her right ankle has massive edema that causes her leg to swell.Additionally, there is sharp pain and a continuous burning sensation at the implant site.She has an appointment to get a biopsy on the (b)(6) 2024 to rule out infection.
Additional Manufacturer Narrative
Correction - cat no, lot no, h6 device code and h6 method code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Failure of total ankle replacement (tar) over time is a known complication.In case of a planned revision procedure a medical opinion aiming to determine the root cause of the failure is part of the internal investigation process.Sufficient (radiological and clinical) information must be provided to enable a meaningful clinical assessment and to identify possible causes of failure.In cases where a ct scan is the only available clinical source, this assessment is limited.No conclusive statement can be provided, because key clinical information (e.G.Clinical status, exact symptoms and range of motion of the patient, assessment of the treating physician) is missing.The root causes of radiographic findings such as radiolucent areas and bone cysts are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure or the device in relation to cause of the failure.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.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.
Event or Problem Description
Reporter called to inform the fda that a stryker right ankle implant that she received in 2022 has failed.Implant failure was confirmed with a computed tomography (ct) where, the device has been shown to have separated and come apart.Reporter stated that since having the implant, she has been very sick and believes she may be having a reaction to the implant.Presently, her right ankle has massive edema that causes her leg to swell.Additionally, there is sharp pain and a continuous burning sensation at the implant site.She has an appointment to get a biopsy on the (b)(6) 2024 to rule out infection.

• Brand Name: INFINITY ADAPTIS TIB 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.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20946447
• Report Number: 3010667733-2024-01066
• Device Sequence Number: 8135380
• Product Code: HSN
• UDI-Device Identifier: 00889797069632
• UDI-Public: (01)00889797069632(11)201125(17)281123(10)1639064
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33680001
• Device Lot Number: 1639064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2020
• 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: Female