MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA STEM EXTENSION TAPERED CEMENTED; PROSTHESIS, KNEE

Catalog Number	42560007514
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after cementing, the stem moved during tibial plate impaction and had detached from the tibial plate.Imaging was performed to confirm that the device had dislodged.There was a 30 minute surgical delay.The surgical technique was utilized.A new stem was implanted successfully, attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign country: japan h6: mechanical (g04) - stem customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: PERSONA STEM EXTENSION TAPERED CEMENTED
• 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: 25546205
• Report Number: 0001822565-2026-01971
• Device Sequence Number: 5585551
• Product Code: JWH
• UDI-Device Identifier: 00887868249594
• UDI-Public: (01)00887868249594(17)351216(10)67654195
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 42560007514
• Device Lot Number: 67654195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2025
• 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
• Patient Sex: Unknown