MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS+ TIB BRG 59X10; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001825034-2021-01726, 0001825034-2021-01727.Medical product: vngd ps open intl fem-rt 57.5, item# 183102, lot# j6448073.Vanguard fem pegs set 2, item# 183099, lot# 329220.Biomet bc r 1x40 us, item# 110035368 lot# 915faa0805.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.
Event or Problem Description
It was reported that a patient was revised approximately one year and one-month post implantation due to instability.Attempts to obtain additional information have been made; however, no more information is available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.No product was returned or no photographs were provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.Root cause cannot be determined.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: E1 VNGD PS+ TIB BRG 59X10
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11948184
• Report Number: 0001825034-2021-01728
• Device Sequence Number: 11027605
• Product Code: JWH
• UDI-Device Identifier: 00880304480018
• UDI-Public: (01)00880304480018(17)200914(10)328950
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K113550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 09/14/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-183700
• Device Lot Number: 328950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 75