MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE¿ TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 200009902

Device Problems Off-Label Use (1494); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2022

Event Type  malfunction  

Event Description

It was reported that the base stem did not have the plasma spray coating.The surgeon felt comfortable enough to use the implant in the patient.

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

The reported event could be confirmed, since previous complaints have been logged confirming the allegation of missing plasma spray.Based on investigation, the root cause was attributed to manufacturing related issue.The failure was caused by a vendor not applying the plasma coating as intended and an inspector failing to identify this issue at incoming inspection.There has been a nonconformance investigation into the allegation of missing plasma coating.Given that the plasma coating is optional, the product can still execute its intended use without the plasma coating.If the non-conforming product was implanted, the associated risk would defer to the associated risks of the smooth design stems.Additionally, the plasma coating does not dictate the overall diameter of the stem.The coating is within the boundaries of an 18 mm diameter dictated by the machined portions of the stem prior to coating.Overall diameter of the device, and therefore, overall fit of the device in the tibia, should not be affected.Therefore, there are no unknown or new risks associated with this event.The surgeon was aware of the missing plasma coating, but felt comfortable implanting with a 4 piece stem construct.

Event Description

It was reported that the base stem did not have the plasma spray coating.The surgeon felt comfortable enough to use the implant in the patient.

• Brand Name: INBONE¿ TOTAL ANKLE SYSTEM
• 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: 15260350
• MDR Text Key: 303247800
• Report Number: 0001043534-2022-00002
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420123848
• UDI-Public: 00840420123848
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200009902
• Device Catalogue Number: 200009902
• Device Lot Number: 1716575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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