MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 10X79/83; PROSTHESIS, KNEE

Model Number	183460
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: vanguard cr ilok fem-rt 72.5: catalog#183013, lot#j6776666; biomet cc cruciate tray 79mm: catalog#141235, lot#j7072592.Foreign source: germany.Multiple mdr reports have been filed for this event.Please see associated report: 0001825034-2023-00192.The product will not be returning to zimmer biomet for evaluation as the product remains implanted.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, thirteen (13) months post-implantation, the patient underwent an arthroscopy with release procedure due to severe stiffness.The patient's symptoms were reported as resolved the day after the procedure.All components remain implanted.Due diligence is in process for this complaint, to date no further information has been reported.
Event or Problem Description
It was reported via a clinical study that a patient underwent an initial right total knee arthroplasty.Subsequently, seven(7) months post-implantation, the patient underwent an arthroscopy with release procedure due to severe stiffness.During the procedure, it the presence of clear fluid was noted and no loosening of implants was detected.No infection showed on the pathology report.All components remain implanted and the patient's symptoms were reported as resolved.Multiple attempts have been made however it was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Visual and dimensional evaluations of the product 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.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the patient experienced stiffness after the 6 month initial post-ops.Arthroscopy was performed to release the scar tissue, clear fluid was drained from the joint.No implant was found loose.No complication was found during this surgery.Drain removed pod 1, circulation, sensibility and motor function were normal at all times.The patient was mobilized early with free rom and could be mobilized with increasing fwb on the right lower extremity.Furthermore, patient had slight improvement in the rom, knee was stable , no effusion found and wound is free from irritation.This complaint is confirmed.Root cause was unable to 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 at time of this report.

• Brand Name: VNGD CR TIB BRG 10X79/83
• 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: 16278780
• Report Number: 0001825034-2023-00193
• Device Sequence Number: 6390933
• Product Code: JWH
• UDI-Device Identifier: 00880304271210
• UDI-Public: (01)00880304271210(17)260527(10)886460
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 04/28/2023

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: 05/27/2026
• Device Model Number: 183460
• Device Catalogue Number: 183460
• Device Lot Number: 886460
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 02/22/2023; 04/28/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 02/28/2023; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose