MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR STEM 10MM LG; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	200347901
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
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 by the customer that "when dr.(b)(6) was implanting 200347901 (10mm talar stem), she noticed that metal was coming off of the stem and into the patient's bone before impacting".There was a 10-minute delay while a new implant was opened and assembled.The case was completed successfully.Once the stem inside the ankle, there was a metal residue that was left inside the ankle immediately.
Event or Problem Description
It was reported by the customer that "when dr.(b)(6) was implanting 200347901 (10mm talar stem), she noticed that metal was coming off of the stem and into the patient's bone before impacting".There was a 10-minute delay while a new implant was opened and assembled.The case was completed successfully.Once the stem inside the ankle, there was a metal residue that was left inside the ankle immediately.
Additional Manufacturer Narrative
Correction - please refer b2 outcomes attributed to ae.The reported event could not be confirmed since evaluation of the returned device could not recreate the event and nothing out of specification could be identified.Visual examination does not find any noticeable debris following device cleaning.Gqo sme was also forwarded the device.The complaint part was verified on the comparator and no issues were found on the plasma coating surface.The inspected parts meet print specification.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 more information is provided, the case will be reassessed.

• Brand Name: INBONE TALAR STEM 10MM LG
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22028600
• Report Number: 3010667733-2025-00572
• Device Sequence Number: 12849790
• Product Code: HSN
• UDI-Device Identifier: 00889797030830
• UDI-Public: (01)00889797030830(11)240922(17)320922(10)1795446
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: Health Professional
• Device Catalogue Number: 200347901
• Device Lot Number: 1795446
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2024
• 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: Male