MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD TIBIAL BEARING ANTERIOR STABILIZED (AS) 67 MM WIDTH 10 MM THICKNESS; PROSTHESIS, KNEE

Catalog Number	VE189040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Ankylosis (4527); Swelling/ Edema (4577); Arthrofibrosis (4885)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: series a pat w/wr std 28 1 peg: catalog#184702, lot#65783328; biomet cc cruciate tray 67mm: catalog#141232, lot#j7510816; vanguard cr por fem-rt 65: catalog#183048, lot#900670 the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Upon completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Following the procedure, the patient continued having pain and neuropathy in the leg with limited range of motion.Diagnostics revealed damage to the peroneal nerve resulting in foot drop and difficulty ambulating.Physical exam revealed a palpable baker¿s cyst, and x-rays showed excessive tibial slope.Subsequently, approximately four (4) months post-implantation, a manipulation under anesthesia was performed due to ankylosis and arthrofibrosis.All available information has been provided.
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: h4.The product was evaluated through manufacturing review and medical records 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 TIBIAL BEARING ANTERIOR STABILIZED (AS) 67 MM WIDTH 10 MM THICKNESS
• Common Device Name: PROSTHESIS, KNEE
• 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: 23548838
• Report Number: 0001822565-2025-04122
• Device Sequence Number: 21275908
• Product Code: JWH
• UDI-Device Identifier: 00889024564428
• UDI-Public: (01)00889024564428(17)261202(10)65268828
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K183583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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 Catalogue Number: VE189040
• Device Lot Number: 65268828
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native, White