MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 10X63/67; PROSTHESIS, KNEE

Catalog Number	183420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10- medical product: vanguard cr ilok fem-rt 62.5, item# 183006, lot# j6178746.Biomet ilok pri tib tray 67mm, item# 141212, lot# 982290.Series a pat std 31 3 peg, item# 184764, lot# 833420.Biomet finned pri stem 40mm, item# 141314, lot# 138020.H3- customer has indicated that the product will 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 a patient was revised approximately seven years seven and a half months post implantation due to collapse of the implant on one side causing pain.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b1, b3, b4, b5, b7, d2b, d4, d6a, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h11.D6a- initial surgery: (b)(6) 2018.Visual examination of the returned device identified signs of extreme wear with scratches, gouges, pits, and micromotion highlighted as well as the device being fractured.Not all fractured pieces were returned.Sem analysis of the returned bearing identified significant material missing from the left-hand condyle posterior side and some apparent impingement damage on the right-hand condyle posterior side of the intracondylar notch.There were some small gouges or scratches in the superior side that do not appear to be related to the aforementioned damage and are likely due to explanation damage.The superior side shows light pitting, abrasions or burnishing's that are typical with in-vivo use.There were two areas near the anterior of the inferior side that showed possible cold flow plastic deformation.The locking mechanism of the bearing was intact, by laying the bearing in place atop the tibial tray, it could be seen that the damage to the left-hand condyle posterior side aligns with damage to the tibial tray.Dimensional analysis was not performed due to the nature of the wear; however product identifiers were verified.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.This complaint is confirmed.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
It was reported that a patient was revised approximately seven years seven and a half months post implantation due to collapse of the implant on one side causing pain.The patient experienced pain when bearing weight on the operative knee, pain when walking, inability to climb or descend stairs due to significant pain.

• Brand Name: VNGD CR TIB BRG 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: 23933807
• Report Number: 0001825034-2025-04244
• Device Sequence Number: 18509898
• Product Code: JWH
• UDI-Device Identifier: 00880304271050
• UDI-Public: (01)00880304271050(17)230208(10)911740
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: Health Professional
• Device Expiration Date: 02/08/2023
• Device Catalogue Number: 183420
• Device Lot Number: 911740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 102 KG