MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MC VE ASF L 11MM 6-7/CD; PROSTHESIS, KNEE

Catalog Number	42512100411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Numbness (2415); Crepitus (4893)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported from a clinical study that the patient underwent an initial left total knee arthroplasty.Approximately 10 months post-implantation, the patient developed chronic left knee pain accompanied by a grinding sensation and noise when walking.Persistent numbness in the lateral aspect of the knee was also reported.The patient managed these symptoms with tylenol.No additional surgical intervention was performed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10 the event is confirmed.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient presented with chronic left knee pain 10 months post tka.Pain is described as consistent and worsens with activity.Pain is located in the anterior and posterior aspects of knee with grindy sensation and noise when walking, notes a ''lumpy' feeling when sitting, and has persistent numbness on lateral aspect of knee.Patient manages pain with tylenol.On exam, there was tenderness in the posterolateral region with bump/mass tender and hard in this region.X-rays showed slight joint effusion, heterotopic ossification redemonstrated posterior tibia that is slightly progressed.There was no fracture, loosening, or wear seen.A definitive root cause cannot be determined.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 MC VE ASF L 11MM 6-7/CD
• 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 IN ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23509592
• Report Number: 3007963827-2025-00446
• Device Sequence Number: 9785893
• Product Code: MBH
• UDI-Device Identifier: 00889024468986
• UDI-Public: (01)00889024468986(17)290816(10)66680466
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: Lay User/Patient
• Device Catalogue Number: 42512100411
• Device Lot Number: 66680466
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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: Other
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Race: White