MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE(R) TIB TRAY; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 220222903

Device Problem Device Inoperable (1663)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly, after the poly was implanted an intraop x-ray was taken and showed the tray was loose from the base stem.The poly was removed and the surgeon attempted to re-seat the poly.A second poly was opened and implanted but it too was loose and also caused the tibia to crack during insertion.It was realized that the tray would only seat to the base after serious pounding on the back table.The surgeon used a size 4 tray with an 18 base.The surgery was extended 4 hours and the patient suffered a cracked tibia.

Manufacturer Narrative

The devices were returned for evaluation.Overall visual examination does not show any gross deformation on the returned devices.Inspection of the tibial tray shows wear to the morse taper most likely from the attempted attachment of the base stem to the tibial tray.Dimensional analysis was performed and confirms that the inner diameter of the base stem and was within tolerance.The two polys were also returned with one still attached to the tibial tray.Visual examination of the non-mated poly shows damage that was most likely caused during removal of the poly from the tibial tray.

• Brand Name: INBONE(R) TIB TRAY
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 7274480
• MDR Text Key: 100196666
• Report Number: 1043534-2018-00008
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K100886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 220222903
• Device Lot Number: 1611280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/19/2018
• Event Location: Hospital
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TIBIAL STEM; TIBIAL STEM
• Patient Outcome(s): Other
• Patient Age: 60 YR