MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED CR STANDARD RIGHT SIZE 7; PROSTHESIS, KNEE

Catalog Number	42502606202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: articular surface medial congruent (mc) right 12 mm height use with tibia sizes e-f/cr femur sizes 6-7: catalog#42522100712, lot#66079959; tibia cemented 5 degree stemmed right size e: catalog#42532007102, lot#65095143; stem extension tapered cemented 14 mm diameter +30 mm length: catalog#42557000114, lot#65012549; all-poly patella cemented 32 mm diameter: catalog#42540200032, lot#65134431.G2: foreign: australia customer has indicated that the product will not be returned to zimmer biomet for investigation per hospital policy.The investigation is in process.Upon completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, two (2) years and five (5) months post-implantation, the patient underwent revision surgery due to instability.The femoral component, tibial components, and articular surface were exchanged without reported complication.The patellar component remains implanted.All available information has been reported.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10; h11.H6: proposed component code: mechanical (g04) femur.Visual examination of the provided pictures identified explanted knee prosthetic components, including the femoral, tibial, and polyethylene articular surface.The components show signs of wear, tissue and blood are visible.Device history record was reviewed and no discrepancies related to the reported event were found.X-ray provided was not submitted to mmi as the image is undated.The image shows a total knee arthroplasty with no obvious signs of misalignment or gross loosening of the femoral and tibial components.The patellar component, which was not replaced during the revision, is not clearly visible in this view.Root cause was unable to be determined.Reported event was unable to be confirmed.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.

• Brand Name: PERSONA FEMUR CEMENTED CR STANDARD RIGHT SIZE 7
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• 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: 20286860
• Report Number: 3007963827-2024-00358
• Device Sequence Number: 7209024
• Product Code: MBH
• UDI-Device Identifier: 00889024230361
• UDI-Public: (01)00889024230361(17)300630(10)64637881
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/02/2024

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 Catalogue Number: 42502606202
• Device Lot Number: 64637881
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 75 KG