MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR TIBIAL BEARING 10X63/67; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a right knee revision approximately three years post-implantation due to pain, swelling, and instability that interfered with daily living and caused the patient to rely on ambulatory aids.During the revision, the cruciate-retaining 10mm tibial insert was removed and replaced with an anterior-stabilizing 14mm tibial insert.No further issues have been reported.
Additional Manufacturer Narrative
(b)(4).D10 medical devices; unknown vanguard 62.5 cr femur catalog#: ni lot#: j6759951.Biomet cc cruciate tray 67mm catalog#: 141232 lot#: j6582608.Series a pat std 28 3 peg catalog#: 184762 lot#: 147890.Biomet bc r 1x40 us catalog#: 110035368 lot#: 927daa2502.Biomet bc r 1x40 us catalog#: 110035368 lot#: 927daa2502.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient had an initial tka and a revision due to pain, swelling, and instability.The art surface was revised and replaced.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VANGUARD CR TIBIAL BEARING 10X63/67
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20050877
• Report Number: 0001825034-2024-02075
• Device Sequence Number: 20823129
• Product Code: JWH
• UDI-Device Identifier: 00880304271050
• UDI-Public: (01)00880304271050(17)241230(10)226560
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 12/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 183420
• Device Lot Number: 226560
• 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: 07/29/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG