MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA® THE PERSONALIZED KNEE® OSSEOTI®; PROSTHESIS, KNEE

Catalog Number	42535006702
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a primary total knee procedure, the 0° punch would not seat fully and became stuck, riding posteriorly on the sizing plate, which resulted in the implant shifting posteriorly.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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.The following sections were updated: b4, b5; g3; h3; h6.- no product was returned or pictures provided; visual and dimensional evaluations could not be performed.-tibia: review of the device history records found no related deviations or anomalies.- device is used for treatment.- the reported products were reviewed for compatibility with no issues noted.-no medical records were provided.- a definitive root cause cannot be determined.- no corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint is not confirmed.D4: attempts have been made to gather all product identification information and no further information has been provided.Pn: 42539906722 ln: ni 0â keel size d right tibial sizing plate.Pn: 42539902223 ln: ni 0â° keel size c-d tibial broach.Pn: 42539902320 ln: 0â° keel tibial broach inserter/extractor handle.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 is available at the time of this report.

• Brand Name: PERSONA® THE PERSONALIZED KNEE® OSSEOTI®
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23815651
• Report Number: 3007963827-2025-00513
• Device Sequence Number: 13263632
• Product Code: JWH
• UDI-Device Identifier: 00889024631915
• UDI-Public: (01)00889024631915(17)340730(10)66616493
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• 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): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 42535006702
• Device Lot Number: 66616493
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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
• Patient Age: 48 YR
• Patient Sex: Female