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

Catalog Number	200009901
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Discomfort (2330); Inadequate Osseointegration (2646)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that the patient had post traumatic arthritis from a prior pilon fracture.The distal tibial bone was rather soft at the time of surgery- the talar component collapsed into some valgus.The patient had a tibial periprosthetic fracture that required surgery.The patient continues to have discomfort.The physician is planning to revise the patient with longer tibial stem for added stability.The physician plans to have a nail back up in case the bone is too soft and unable to revise.
Additional Manufacturer Narrative
Correction - h6 (device code).The reported event could be confirmed based on available medical record and medical expert assessment.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.Upon further investigation of the ct scans by healthcare professionals the following was observed all components are intact.The tibial component has subsided anteriorly and into a slight varus position.The ct-scan shows an overall poor bone quality (osteopenic appearance).No signs of loosening and/or chronic infection.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by ospenic bone of patient if device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient had post traumatic arthritis from a prior pilon fracture.The distal tibial bone was rather soft at the time of surgery- the talar component collapsed into some valgus.The patient had a tibial periprosthetic fracture that required surgery.The patient continues to have discomfort.The physician is planning to revise the patient with longer tibial stem for added stability.The physician plans to have a nail back up in case the bone is too soft and unable to revise.During a later conversation the physician reported that the implant components were not the cause of the failure, it was the patient's poor quality of bone.They plan on revising in the near future but the patient is currently having cardiac issues and has not been cleared by cardiology.

• Brand Name: INBONE STEM TIBIAL BASE 16MM RIGHT AND 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: 18069709
• Report Number: 3010667733-2023-00665
• Device Sequence Number: 7616005
• Product Code: HSN
• UDI-Device Identifier: 00840420123831
• UDI-Public: 00840420123831
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: 200009901
• Device Lot Number: 1675463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• 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: Required Intervention
• Patient Sex: Female