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

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Reaction (2414)
Date of Event	03/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: femoral component catalog: cp113632 lot#: 122880, tibial tray catalog#: 141211 lot#: 097460, finned stem catalog#: 141314 lot#: 085230, patellar component catalog#: 184762 lot#: 161900.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2015-03681, 0001825034-2015-03679, 0001825034-2015-03680.Reported event was unable to be confirmed due to limited information received from the customer.Review of device history records found these units were released to distribution with no deviations or anomalies.The patient was confirmed to be allergic to acrylates in the bone cement; however, with the information provided, a definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Patient reported to have undergone right total knee arthroplasty.Subsequently, patient underwent a revision procedure approximately 26 months post-implantation due to loosening, pain, burning sensation and an allergy to bone cement.

• Brand Name: E1 VNGD PS TIB BRG
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9564024
• Report Number: 0001825034-2020-00176
• Device Sequence Number: 19549653
• Product Code: JWH
• UDI-Device Identifier: 00880304465787
• UDI-Public: (01)00880304465787
• 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: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2020

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: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: EP-183620
• Device Lot Number: 923100
• 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: 01/06/2020
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 43