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	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported it was reported that two implants were found to be defective during a primary prophecy inbone case.The tibia fractured as a result of the repeated impact to the tibial plate and stem.Arthrex plates and screws were used to manage the fracture as well as bone cement to help fixate the inbone stem.New implants were used to complete the case successfully.There was a 90 minute delay.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported it was reported that two implants were found to be defective during a primary prophecy inbone case.The tibia fractured as a result of the repeated impact to the tibial plate and stem.Arthrex plates and screws were used to manage the fracture as well as bone cement to help fixate the inbone stem.New implants were used to complete the case successfully.There was a 90 minute delay.
Additional Manufacturer Narrative
Correction - h6 (device code).The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.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.A device inspection was performed by gqo team for returned devices and following was observed- both inbone tibial tray and tibial base was determined to be within specification.It appears that the surface damage was caused at the time of surgery/ implantation.It appears that the implant was overexerted during surgery/implantation.The surface damage could have impacted how the tray locks in.Dimensionally, everything was within specification.Based on the available information, the failure is likely to be user related.Failure is most likely caused by application of higher force during impaction that resulted in surface damage of tibial tray and affected its functionality.If more information is provided, the case will be reassessed.

• 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: 19071610
• Report Number: 3010667733-2024-00191
• Device Sequence Number: 11932952
• Product Code: HSN
• UDI-Device Identifier: 00840420123831
• UDI-Public: 00840420123831
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 1763257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: Unknown