MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING (CCK) RIGHT 26 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.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 was revised for instability due to a fractured lcck post.Only the bearing was revised.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4, b5, g3, g6, h1, h2, h3, h4, h6, h10, h11.Visual examination of the provided pictures identified a fractured cck articular surface bearing, no device was returned therefore no further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing.Insufficient information provided to perform a compatibility check.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the right knee demonstrate a right total knee arthroplasty with oblique appearance of the tibial tray which could indicate broken hardware and possible withdrawal of the locking screw mechanism.Radiolucency along the bone cement interface of the tibial component and the femoral component suggest loosening.Overall sizing of the hardware is appropriate.Complaint can be confirmed through the photo provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 available at the time of this report.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING (CCK) RIGHT 26 MM
• 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: 20738248
• Report Number: 0001822565-2024-03648
• Device Sequence Number: 20994749
• Product Code: JWH
• UDI-Device Identifier: 00889024555204
• UDI-Public: (01)00889024555204(17)250810(10)64580615
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 08/10/2025
• Device Model Number: N/A
• Device Catalogue Number: 42522800526
• Device Lot Number: 64580615
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• 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