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

Catalog Number 200011902

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Osteolysis (2377); Limb Fracture (4518)

Event Date 08/15/2023

Event Type  Injury  

Event Description

It was reported that the patient had to undergo a revision surgery due to the infection.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device disposition unknown.

Event Description

It was reported that the patient had to undergo a revision surgery due to the infection.

Manufacturer Narrative

The reported event could be confirmed since images of ct scans were provided and shows a girdlestone-situation with a cement spacer at the ankle joint.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿it is confirmed that there is an infection present at the site of the former tar.There is a girdlestone-situation with a cement spacer at the ankle joint.If-what is likely-there is a late infection (>6months after index operation) the case can be considered as being completely patient related.Additional observations noted was that there is a consolidated old tibial shaft fracture visible, which seems to have healed in a slight axis deviation in the sagittal and the coronal plane.This may have resulted in slight load peaks that led to increased stress on the implant.The infection and revision of the infection site left a large cavity with complete loss of the ventral tibial cortex and may require sufficient reconstruction measurements in a future revision.¿ based on investigation, the root cause was attributed to a patient related issue.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.

• Brand Name: INBONE STEM, TIBIAL, TOP SIZE, 16 MM, RIGHT AND LEFT
• Type of Device: 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: 17712466
• MDR Text Key: 322981506
• Report Number: 3010667733-2023-00516
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420123909
• UDI-Public: 00840420123909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 200011902
• Device Lot Number: 1735772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male