MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA CRUCIATE RETAINING CEMENTED STANDARD FEMORAL COMPONENT SIZE 9 LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona ultra congruent articular surface 14mm size gh catalog #: 42511200614 lot #: 63659264 persona cemented all poly patella 35mm catalog #: 42540000035 lot #: 64156998 persona stemmed cemented tibial tray left size g catalog #: 42532007901 lot #: 64037694 the complainant 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.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address unspecified femoral component failure and polyethylene debris approximately six (6) years post-operatively.Attempts have been made; however, no additional 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, h2, h6, h11.
Event or Problem Description
It was reported that the patient underwent a left knee arthroplasty revision to address femoral component loosening and polyethylene debris and pitting approximately six (6) years post-operatively.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.H6 - component code - proposed code is mechanical (g04) - femur.Visual evaluation of the returned articular surface identified pitting and wear marks on the proximal surface as well as nicks and gouges on the distal surface, confirming implantation and explantation.The femoral component was evaluated through manufacturing review; however, the device was not returned and therefore the event could not be confirmed for the femoral component.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 CRUCIATE RETAINING CEMENTED STANDARD FEMORAL COMPONENT SIZE 9 LEFT
• 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: 20476806
• Report Number: 3007963827-2024-00409
• Device Sequence Number: 18010235
• Product Code: JWH
• UDI-Device Identifier: 00889024230392
• UDI-Public: (01)00889024230392(17)280630(10)63992832
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2025

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: 42502606601
• Device Lot Number: 63992832
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 02/06/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/02/2024; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2018
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male