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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Fibrosis (3167)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - unknown biomet tibial tray catalog #: ni lot #: ni, unknown biomet tibial bearing catalog #: ni lot #: ni.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.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 underwent a left knee manipulation under anesthesia to address stiffness approximately six (6) weeks following left knee arthroplasty.The patient ultimately underwent a left knee arthroplasty revision approximately eight (8) months following the manipulation due to continued complaints of pain, stiffness as well as femoral and tibial implant loosening.Initial operative notes noted no intraoperative complications.Revision operative notes noted significant arthrofibrosis, which was excised.The tibial and femoral components were noted to be loose and were revised.The patellar implant was well-fixed and remained implanted.No intraoperative complications were noted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
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 information.The following sections were updated: b4, d4, g3, g6, h2, h3, h4, h6, h11.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: VANGUARD CRUCIATE RETAINING FEMORAL COMPONENT LEFT 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: 21654705
• Report Number: 0001825034-2025-00766
• Device Sequence Number: 18026531
• Product Code: JWH
• UDI-Device Identifier: 00880304270558
• UDI-Public: (01)00880304270558(17)301204(10)J6920004
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 183034
• Device Lot Number: J6920004
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 03/20/2025; 07/09/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/10/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White