MAUDE Adverse Event Report: Zimmer Biomet, Inc. VANGUARD TI FEM CR 72.5MM RT; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented

Catalog Number	CP113624
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right total knee arthroplasty and was subsequently revised approximately 18 months post-implantation due to pain, instability, and aseptic loosening.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: concomitant products: 141215 - biomet ilock pri tib tray - 66331829.141314 - biomet finnd pri stem - 66392313.184770 - series a pat std - 65924540.Ve189100 - tibial bearing as 79mm - 65653362.Unknown biomet bone cement.H6: component code: mechanical (g04) - femur.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: VANGUARD TI FEM CR 72.5MM RT
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented
• 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 ; +1(574)526-0384
• MDR Report Key: 50120648
• Report Number: 0001825034-2026-02262
• Device Sequence Number: 18696231
• Product Code: JWH
• UDI-Device Identifier: 00880304653597
• UDI-Public: (01)00880304653597(17)280919(10)173050
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/19/2018
• Device Catalogue Number: CP113624
• Device Lot Number: 173050
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2018
• 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 Narrative.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 210 LB