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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: persona femur cemented cruciate retaining (cr) standard catalog # 42502606801 lot # 65928905.Stem extension tapered cemented 14 mm diameter +30 mm length catalog # 42557000114 lot # 68318960.Tibia fixed cemented left size g stem extension use required catalog # 42542007901 lot # 66060152.Tibial central cone size fixed tibia catalog # 42545000508 lot # 65648707.2.5 mm female hex screw 25 mm length catalog # 42509902525 lot # 65766851.Palacos cement catalog # 66044272 lot # l123.G2: australia.H3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure nine months post implantation due to loosening and instability.During the revision, it was found that the medial collateral ligament was failing to contain the flexion gap, and the medial compartment would open with flexion.A thicker medial congruent articular surface was attempted but found insufficient.Therefore, the femoral component was revised as well.All tibial implants were left in place.No intraop complications occurred, and the joint was stable in full range of motion at the end of the case.It is unknown at this time if articular surface was loose.No more information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11.Reported event was confirmed by review of x-rays provided.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Operative notes review indicates that the patient underwent a left knee arthroplasty revision due to instability and loosening.During the procedure, it was observed that the medial collateral ligament failed to contain the flexion gap, causing significant opening of the medial compartment.A thicker medial congruent articular surface was attempted but was found insufficient, leading to the decision to revise the femoral component.The distal femur was recut.The femoral component was positioned and aligned with cemented stem.The patella was not resurfaced due to a concave wear pattern.Full extension and maximum flexion were achieved, and a positive clinical outcome was noted at the end of the procedure.No intraoperative complications were reported.X-ray review indicates that the overall fit and alignment of the implants are appropriate.There is loosening of the femoral component, with possible mild radiolucency at the cement-hardware interface.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 available at the time of this report.

• Brand Name: PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC)
• 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: 20925525
• Report Number: 3007963827-2024-00506
• Device Sequence Number: 18222640
• Product Code: MBH
• UDI-Device Identifier: 00889024469372
• UDI-Public: (01)00889024469372(17)280709(10)65917374
• 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: 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): 03/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512100910
• Device Lot Number: 65917374
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male