MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 14 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522100914
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: catalog: 42502606802, femur cemented cruciate retaining (cr) standard right size 10, lot: 65958504.Unknown catalog#, unk tibial component, unknown lot#.G2: foreign: australia.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 the patient underwent an initial knee procedure.Subsequently, the patient was revised on the same date due to infection.Implants were in situ as spacer for infected joint with plan to revise at later date if infection cleared.Infection has not cleared, so implants removed, and cement spacer placed in situ after washing out.Attempts have been made, and no additional information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: catalog: 42502606802, femur cemented cruciate retaining (cr) standard right size 10, lot: 65958504.This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2b; d6a; d10; g3; g6; h1; h2.Upon receiving additional information and reassessment of the reported event, it was determined to be not reportable as the device was implanted while an infection was already present, therefore the device is not considered a contributory cause to the event.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
It was reported the patient underwent an initial knee procedure, where femoral component and poly were used as spacers; this procedure was done on a native knee that was infected.Subsequently, the patient was revised, but the infection was not cleared, so implants were removed, and cement spacers were placed in situ after wash out.Attempts have been made, and all the available information has been provided.

• Brand Name: PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 14 MM HEIGHT
• 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21890442
• Report Number: 3007963827-2025-00162
• Device Sequence Number: 12791116
• Product Code: MBH
• UDI-Device Identifier: 00889024242517
• UDI-Public: (01)00889024242517(17)260504(10)65115800
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 05/19/2025

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: Health Professional
• Device Expiration Date: 05/04/2026
• Device Catalogue Number: 42522100914
• Device Lot Number: 65115800
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2021
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown