MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS TIB BRG 63/67X10; PROSTHESIS, KNEE

Model Number	EP-183620
Medical Device Problem Codes	Off-Label Use (1494); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni; biomet tibial locking bar: catalog#141205, lot#65766411; all poly petella standard cemented size 32 mm diameter 8.5 mm thickness: catalog#00597206532, lot#65335109; optip 40 refob plus bone cmt-3: catalog#4720502083-3, lot#ax31af0705.G2: foreign: (b)(6).The product will not be returned 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.H3 other text : see h10 narrative.
Event or Problem Description
It was reported that a patient underwent a revision knee procedure for a polyethylene insert exchange.After the procedure, it was determined that the newly implanted articular surface is not compatible with the previously implanted femoral component.No additional medical intervention has been reported to correct the incorrectly implanted component.Due diligence is in progress for this event; to date no additional information has been provided.
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: 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.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: femur and articular surface.Complaint is confirmed.Investigation results concluded that the reported event is attributed to user not following instructions.The surgeon used a posterior stabilized articular surface with cruciate retaining femoral component.Per total knee compatibility matrix, the suggested use indicates only a cruciate retaining femur should be used with a cruciate retaining articular surface.A summary of the investigation was not sent to the complainant conveying appropriate compatibility as the and surgeon indicated awareness of the off-label use.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: E1 VNGD PS TIB BRG 63/67X10
• 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: 17088971
• Report Number: 0001825034-2023-01311
• Device Sequence Number: 12305122
• Product Code: JWH
• UDI-Device Identifier: 00880304465787
• UDI-Public: (01)00880304465787(17)260628(10)106610
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2026
• Device Model Number: EP-183620
• Device Catalogue Number: EP-183620
• Device Lot Number: 106610
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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
• Patient Sex: Prefer Not To Disclose