MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 14MM HEIGHT SIZE E ARTICULAR SURFACE WITH HINGE POST EXTENSION; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: 15mm diameter 30mm length straight stem extension combined length 75mm catalog#: 00598801215, lot#: 63439869.Size 3 precoat cemented tibial component catalog#: 00588000300, lot#: 77006219.Right size e cemented option femoral component catalog#: 00588001502, lot#: 63719584.16mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801016, lot#: 63608671.Palacos r + g (1x40) catalog#: 66022663, lot#: 86614635.Palacos r + g (1x40) catalog#: 66022663, lot#: 86614635.Palacos r + g (1x40) catalog#: 66022663, lot#: 86614635.Palacos r + g (1x40) catalog#: 66022663, lot#: 86614635.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent a right knee revision approximately six years post implantation for an unknown reason.The tibial insert was removed and replaced.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported the patient underwent a right knee revision approximately six years post implantation due to instability.The tibial insert was removed and replaced.No additional patient consequences were reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned and pictures provided were insufficient to perform a visual and dimensional evaluation.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right total knee arthroplasty without definite hardware failure or loosening.Device history record was reviewed and no discrepancies were found.Review of complaint history from found no additional related issues for this item and the reported part and lot combination.The root cause of the reported instability is attributed to incompatible components as the surgeon used tibial plate size 3 with this articular surface.The product label indicates that this articular surface should be used with tibial plate size 4, 5, 6.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• Brand Name: 14MM HEIGHT SIZE E ARTICULAR SURFACE WITH HINGE POST EXTENSION
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18124264
• Report Number: 0001822565-2023-03159
• Device Sequence Number: 6703591
• Product Code: JWH
• UDI-Device Identifier: 00889024199378
• UDI-Public: (01)00889024199378(17)220531(10)63680540
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 02/27/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00588005014
• Device Lot Number: 63680540
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/27/2023; 02/20/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/22/2023; 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female