MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 71/75X10; PROSTHESIS, KNEE

Catalog Number	EP-183640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the month following a left total knee arthroplasty was performed, a patient was admitted to the hospital for treatment of left leg dvt.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
(b)(4) d10- medical product, van ps open intl fem-lt 67.5, item# 183130, lot# j3976657, biomet cc cruciate tray 75mm , item# 141234, lot# j6043459, bmet arcom ap pat 3pst 31mm sm, item# 11-150840, lot# 160190, cobalt g-hv bone cement 40g, item# 402283, lot# 745920.H3- customer 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.

• Brand Name: E1 VNGD PS TIB BRG 71/75X10
• 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: 24640504
• Report Number: 0001825034-2026-00633
• Device Sequence Number: 9787070
• Product Code: JWH
• UDI-Device Identifier: 00880304465749
• UDI-Public: (01)00880304465749(17)220609(10)879940
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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 Expiration Date: 06/09/2022
• Device Catalogue Number: EP-183640
• Device Lot Number: 879940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White