MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA REV CCK VE; PROSTHESIS KNEE

Catalog Number	42522800710
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: patella reamer blade with pilot hole 35 mm diameter single use only catalog # 00597909535 lot # 64613794; femur cemented plus right size 9+ catalog # 42504606612 lot # 64667173; stem extension 6mm offset splined uncemented 20 mm diameter +135 mm length catalog # 42560613520 lot # 64847705; tibia fixed cemented right size f stem extension use required catalog # 42542007502 lot # 64599654; stem extension 6mm offset splined uncemented 17 mm diameter +135 mm length catalog # 42560613517 lot # 64701380; tibial central cone size small catalog # 42545000511 lot # 64492742; headless trocar drill pin 3.2 mm diameter 75 mm length catalog # 00590102000 lot # 64866928; thin osteotome blade 10mm x 3 catalog # 47998602121 lot # 56702913; all poly patella cemented 35 mm diameter catalog # 42540000035 lot # 64830163.H3: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure four years post implantation due sheared implant.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, g3, h2, h3, h4; h6.The reported event was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause could not be determined.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 to report.

• Brand Name: PERSONA REV CCK VE
• 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: 21525490
• Report Number: 0001822565-2025-00529
• Device Sequence Number: 9712980
• Product Code: JWH
• UDI-Device Identifier: 00889024555303
• UDI-Public: (01)00889024555303(17)250430(10)64709652
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/16/2025

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
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 42522800710
• Device Lot Number: 64709652
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2020
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male