MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 3 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	220220903
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a device explant surgery due to talus loss of bone.The patient received a cement spacer.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection revealed the following: visual examination of the received products shows that they are visible in a used condition, as fine scratches on the joint tread shown at the talar dome, which are most likely are result from removal.Furthermore, the implant has white residue around the talar stem, based on that we are not able to separate those two parts.The residue is most likely bone tissue.In addition, the parts are in a good condition, including an intact plasma coating.Dimensional inspection, the measurements taken are all within accuracy.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient underwent a device explant surgery due to talus loss of bone.The patient received a cement spacer.

• Brand Name: INBONE TALAR DOME SZ 3 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: 18779365
• Report Number: 3010667733-2024-00102
• Device Sequence Number: 8382594
• Product Code: HSN
• UDI-Device Identifier: 00840420124227
• UDI-Public: 00840420124227
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 220220903
• Device Lot Number: 1672991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2023
• 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 Age: 74 YR
• Patient Sex: Male