MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM, TIBIAL, BASE SIZE, 16 MM, RIGHT & LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	200009901
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Limb Fracture (4518); Insufficient Information (4580)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, there was posterior subsidence of the tibial implant.The patient will continue to be monitored and no further intervention will be performed.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Allegedly, there was posterior subsidence of the tibial implant.The patient will continue to be monitored and no further intervention will be performed.
Additional Manufacturer Narrative
Correction: h6 (device code) the reported event could be confirmed based on available medical record and health care expert¿s opinion.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.Formal medical opinion was sought from an experienced independent medical expert as below; ¿there is a clear radiolucence around the tibial components suggesting loosening.The pe cannot be assessed directly, however, there is no sign of loosening or breakage of the implant visible.The talar component shows radiolucence, some cysts and posteriorly a fracture line is visible.Loosening and a periprosthetic fracture can be assumed.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused by cysts and cavities around talus component.As secondary observation periprosthetic fracture was noticed if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INBONE STEM, TIBIAL, BASE SIZE, 16 MM, RIGHT & LEFT
• 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: 16682972
• Report Number: 3010667733-2023-00174
• Device Sequence Number: 15300694
• Product Code: HSN
• UDI-Device Identifier: 00840420123831
• UDI-Public: 00840420123831
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 200009901
• Device Catalogue Number: 200009901
• Device Lot Number: 1697577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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: Other
• Patient Age: 49 YR
• Patient Sex: Unknown
• Patient Weight: 145 KG