MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS TIB BRG 12X71/75MM; PROSTHESIS, KNEE

Model Number	183642
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: tinbn vg int ps anat fm l 70mm: catalog#18132tnbn, lot#3560859; tnbn pol cocr fin tib tray 71: catalog#141253tnbn, lot#2017051899; unknown tibial stem: catalog#ni, lot#ni; unknown patella component: catalog#ni, lot#ni; refobacin bone cement: catalog#ni, lot#ni.Report source: foreign: italy.Customer has indicated that the product will not be returning to zimmer biomet for evaluation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow up report will be submitted.
Event or Problem Description
It was reported via a clinical study that a patient underwent an initial left total knee arthroplasty.Approximately one year and two months post implantation, the patient underwent revision surgery due to pain.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: visual and dimensional evaluations could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Per package insert, pain is known adverse effect of the system.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VNGD PS TIB BRG 12X71/75MM
• 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: 15063934
• Report Number: 0001825034-2022-01649
• Device Sequence Number: 5722771
• Product Code: JWH
• UDI-Device Identifier: 00880304271944
• UDI-Public: (01)00880304271944(17)220726(10)430510
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: Health Professional
• Device Expiration Date: 07/26/2022
• Device Model Number: 183642
• Device Catalogue Number: 183642
• Device Lot Number: 430510
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2017
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 80 KG