MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL FEMUR CEMENTED SIZE 5 RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42528200708 - partial articular surface right medial size g 8 mm thickness - 64660649.42538000702 - partial tibial cemented size g right medial - 65032727.G2 : foreign country : new zealand.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.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty.Subsequently 2.5 years post-op, the patient was revised due to pain.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number #3007963827-2024-00469.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 PARTIAL FEMUR CEMENTED SIZE 5 RIGHT MEDIAL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19529252
• Report Number: 0001825034-2024-01586
• Device Sequence Number: 7560538
• Product Code: HSX
• UDI-Device Identifier: 00880304808560
• UDI-Public: (01)00880304808560(17)310219(10)64944836
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 11/19/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000502
• Device Lot Number: 64944836
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose