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

Catalog Number	183460
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Insufficient Information (4580); Joint effusion (4849)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, six (6) years and eight (8) months post-implantation, the patient underwent revision surgery due to wear of the articular surface.The bearing was exchanged without reported complication.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
(b)(4).Date of implant: exact date of implant is unknown however occurred in (b)(6) 2017.Medical product: unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni.G2: foreign: germany.Diligence is in process to determine whether the product is available for evaluation.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
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Upon receipt of additional information or 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: a1; b3; b4; b5; b7; d6; d9; d10; g3; h2; h6; h11.D10: medical product: unknown vanguard cr femoral component: catalog#ni, lot#ni; unknown vanguard cr tibial tray: catalog#ni, lot#ni; unknown refobacin cement: catalog#ni, lot#ni.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, six (6) years and eight (8) months post-implantation, the patient experienced swelling and instability and underwent revision surgery.During the procedure, the polyethylene bearing was noted to have posterior wear.After extensive soft tissue balancing, the bearing was exchanged without reported complication.All available information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the proximal and distal surface to exhibit wear and damage.The device was submitted for further analysis.Analysis determined the damage to the bearing surface is potentially due to overloading, possibly exacerbated by a misalignment causing extensive overloading on the right-hand posterior condyle.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision surgical notes: eua positive for instability, posterior wear noted on the inlay, new anterior stabilizing poly placed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total knee arthroplasty with medial compartment narrowing and metal on metal appearance suggesting polyethylene wear.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was confirmed.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.
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: 18685644
• Report Number: 0001825034-2024-00375
• Device Sequence Number: 17737415
• Product Code: JWH
• UDI-Device Identifier: 00880304271210
• UDI-Public: (01)00880304271210(17)220317(10)990770
• 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: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/29/2024

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: 03/17/2022
• Device Catalogue Number: 183460
• Device Lot Number: 990770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 07/25/2024; 08/28/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 05/01/2024; 08/01/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 99 KG