MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT RIGHT 75MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Insufficient Device Problem Information (3190); Noise, Audible (3273)
Health Effect - Clinical Codes	Fall (1848); Deformity/ Disfigurement (2360); Ambulation or Postural Difficulties (2544); Subluxation (4525); Joint Laxity (4526); Unequal Limb Length (4534); Insufficient Information (4580); Crepitus (4893)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - biomet polished finned tibial tray 83mm catalog #: 141256 lot #: 2120007393, vanguard anterior stabilized tibial bearing 10mm x 83mm catalog #: 189120 lot #: 66151333.G2 - report source - foreign: event occurred in russia.H6 - component code - proposed code is mechanical (g04) - femur.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient experienced unknown complications following right knee arthroplasty.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a3, a4, b4, b5, b6, b7, d6a, g3, g6, h2, h6, h10, h11.
Event or Problem Description
It was reported that the patient has been recommended to undergo a right knee arthroplasty revision approximately three (3) months post-operatively to address continued instability, severe varus deformity, tibial component subluxation, limited flexion and crepitus.The patient has undergone physiotherapy, magnetic therapy, laser therapy, massage and utilizes a knee brace and cane for walking.Initial operative notes noted no intraoperative complications.However, the patient's discharge summary noted that the patient's knee joint was deformed and deflected with severe varus deformity of the lower extremity noted.The patient was noted to have preserved active knee motion, but was significantly limited with moderate hypotrophy of the thigh, a pronounced crunching sound with movement and pain.Attempts have been made, however, no additional information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: d4, h4.The product was evaluated through manufacturing review and medical records provided confirmed the reported event.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT RIGHT 75MM
• 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: 24118970
• Report Number: 0001825034-2026-00169
• Device Sequence Number: 15786499
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 183014
• Device Lot Number: J7527841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 03/12/2026; 06/18/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 04/07/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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: Other
• Patient Sex: Male
• Patient Weight: 224 LB