MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ASF CPS 14MM VE R 6-9 EF; PROSTHESIS, KNEE

Catalog Number	42522600714
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a revision for unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D2, d4, g4: diligence is in process to provide product identification information; however, no further information has been provided at this time.D10: unk femoral lot# unk, unk tibial lot# unk.G2: australia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information and reassessment of the reported event, it was determined to be not reportable.The initial report should be voided.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA ASF CPS 14MM VE R 6-9 EF
• 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: 23366722
• Report Number: 0001822565-2025-03832
• Device Sequence Number: 15682512
• Product Code: MBH
• UDI-Device Identifier: 00889024244603
• UDI-Public: (01)00889024244603(17)250923(10)64804586
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/23/2025
• Device Catalogue Number: 42522600714
• Device Lot Number: 64804586
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown