MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 0A KEEL LEFT SIZE E CEMENTED TIBIA; PROSTHESIS, KNEE

Catalog Number	42536007101
Medical Device Problem Codes	Off-Label Use (1494); Device packaging look-alike (4079); Device label look-alike (4081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
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 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 through a user report that during an left total knee arthroplasty, the surgeon intended to use a press-fit, noncemented system.However, a cemented tibial plate was mistakenly implanted into the patient rather than a noncemented plate, and no cement was used.Subsequently, the patient was revised 4 days later to correct the tibial component.Reporter claims that human error occurred because the packaging of the two different device lines, cemented vs noncemented, are too similar.There is no other alleged malfunction against the device, and patient did not experience any other harm or impact as a result of the incorrect plate being implanted.Attempts have been made and all information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h2, h3, h6.The reported event could not be confirmed due to insufficient information provided.Visual examination of the provided picture identified a label for a keel tibia with (cemented) printed on it.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to user error.The tibia component used was designed for cemented fixation but was implanted without cement.According to 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¿.The label provided has (cemented) printed on it.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 additional information at this time.

• Brand Name: PERSONA 0A KEEL LEFT SIZE E 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: 23378785
• Report Number: 0001822565-2025-03845
• Device Sequence Number: 18348926
• Product Code: JWH
• UDI-Device Identifier: 00889024632103
• UDI-Public: (01)00889024632103(17)340903(10)66830725
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 42536007101
• Device Lot Number: 66830725
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 81 KG