MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 0° KEEL RIGHT SIZE F CEMENTED TIBIA; PROSTHESIS, KNEE

Catalog Number	42536007502
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right knee surgery.After the surgery, the surgeon then discovered that they did not use cement when implanting the tibial component.Subsequently, the patient was revised where all of the implants were exchanged and cemented.The patella was also resurfaced and a patella implant was placed.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42508006602 - cruciate retaining right size 9 pps narrow femur - 66523290.42522100811 - articular surface medial congruent (mc) right 11 mm height use with tibia sizes e-f/cr femur sizes 8-11 - 66100772.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.The event is confirmed.Visual examination of the provided pictures identified explanted devices with foreign material on the surfaces.As the device was not returned, further evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The root cause is attributed to a failure to follow instructions for not using cement.Per the instructions for use, ''porous coated components may be used cemented or uncemented (biological fixation), except for the persona osseoti keel tibia which is for uncemented use only.All other femoral, tibial baseplate and all-polyethylene (uhmwpe and vehxpe) patella components are indicated for cemented use only.'' a porous coated component was not used.Therefore, cement should have been used.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA 0° KEEL RIGHT SIZE F CEMENTED TIBIA
• 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: 22826554
• Report Number: 0001822565-2025-02970
• Device Sequence Number: 4577909
• Product Code: JWH
• UDI-Device Identifier: 00889024632134
• UDI-Public: (01)00889024632134(17)340406(10)66546003
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/19/2025

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: Lay User/Patient
• Device Catalogue Number: 42536007502
• Device Lot Number: 66546003
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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 H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male