MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL INSERT COMPONENT SIZE 4 ORANGE; ANKLE, PROSTHESIS

Model Number	00-4500-044-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00962, 0001822565-2023-00964.Concomitant medical product(s): tibial base component size 4 orange for use with size 4 talar components only cat: 00830004400 lot: 63282882; talar component size 4 right orange for use with size 4 tibial components only cat: 00830002400 lot: 62977592.Report source foreign country: switzerland.Product remains implanted.
Event or Problem Description
It was reported that a patient experiencing pain approximately 6 years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that a patient experiencing pain approximately 6 years post implantation.The surgeon stated pain is likely due to impingement or painful scars / soft tissue.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed.No product, pictures, or medical records were provided for visual, dimensional, or healthcare professional evaluation.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TIBIAL INSERT COMPONENT SIZE 4 ORANGE
• Common Device Name: ANKLE, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16709482
• Report Number: 0001822565-2023-00967
• Device Sequence Number: 17622505
• Product Code: HSN
• UDI-Device Identifier: 00889024269668
• UDI-Public: (01)00889024269668(17)210331
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120906
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2023

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 00-4500-044-00
• Device Catalogue Number: 00830005400
• Device Lot Number: 63325722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 08/07/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/07/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2016
• 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: Other
• Patient Sex: Male