MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 2 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	220220902
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the patient required a revision surgery due to tibial tray loosening 6 weeks post-op.The patient was diagnosed with rheumatoid arthritis after the initial surgery.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was explanted and returned for evaluation.The device inspection revealed the following: visual examination of the returned implant confirms the catalog and lot number.Remnants of biological material could be seen on the talar dome.Scratches and blemishes are visible on the superior side of the talar dome.Key dimensional measurements were taken with a digital caliper and found to be within dimensional specifications.Upon further investigation of the received information by healthcare professionals the following was observed: ¿from the additional information given in this case (failure six weeks after the implantation but no confirmed infection) it can be assumed, that the poor bone stock and additional patient related problems (ra) have contributed to the failure.A different implant would have been chosen by the surgeon-at least that is stated- to prevent the implant from early loosening.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was most likely caused by poor bone stock and the rheumatoid arthritis experienced by the patient.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient required a revision surgery due to tibial tray loosening 6 weeks post-op.The patient was diagnosed with rheumatoid arthritis after the initial surgery.

• Brand Name: INBONE TALAR DOME SZ 2 SULCUS
• 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: 18342200
• Report Number: 3010667733-2023-00781
• Device Sequence Number: 15559699
• Product Code: HSN
• UDI-Device Identifier: 00840420124210
• UDI-Public: 00840420124210
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 220220902
• Device Lot Number: 1705489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 12/17/2023
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2021
• 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