MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 5 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680035
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported that one of the pegs on the talar dome broke.There is no intervention planned at this time.
Additional Manufacturer Narrative
The reported event could be confirmed since x-ray images were provided and shows the medial anterior peg on the talar dome is broken.Upon further investigation of the x-ray images by healthcare professionals the following was observed: ¿breakage of the medial anterior peg.There is no relevant sign of loosening or migration visible.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that one of the pegs on the talar dome broke.There is no intervention planned at this time.

• Brand Name: FLAT CUT TALAR DOME SZ 5 INFINITY ADAPTIS
• 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: 18119457
• Report Number: 3010667733-2023-00681
• Device Sequence Number: 17861290
• Product Code: HSN
• UDI-Device Identifier: 00889797073097
• UDI-Public: 00889797073097
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33680035
• Device Lot Number: 1684349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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
• Patient Age: 70 YR
• Patient Sex: Male