MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MC VE ASF L 10MM 8-11/GH; PROSTHESIS, KNEE

Catalog Number	42512100910
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint locking (2672); Joint Laxity (4526); Swelling/ Edema (4577); Crepitus (4893)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Two (2) months post-implantation, the patient reported experienced a fall which led to increased pain, decreased range of motion and trouble bearing weight.Two (2) months following the fall, the pain continued with the feeling of the knee moving and locking up.A knee aspiration was performed that was negative.A second knee aspiration done two weeks later that was also negative and a cortisone injection was given.Five (5) months post-fall, the patient outcome is pending as the pain, swelling, crepitus and range of motion and weight bearing issues continue regardless of intervention.Due diligence is in progress for this event; to date all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: psn all poly pat ply 38mm: catalog#42540000038, lot#66526117; unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni; biomet bc r 1x40 us: catalog#110035368, lot#w49aak1701.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h4; h6; h10; h11.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records was not performed.Investigation results concluded that the root cause of the reported event is attributed to non-device related factors.It was reported a patient slipped and fell in the garage and began having increased pain, decreased range of motion, trouble bearing weight, crepitus, and the knee locking up.As the complaint indicates, the patient sustained an external trauma that caused the complication with no allegations against the device prior to the event.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.
Event or Problem Description
No further event information at time of this report.

• Brand Name: PERSONA MC VE ASF L 10MM 8-11/GH
• 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
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22898037
• Report Number: 3007963827-2025-00332
• Device Sequence Number: 21056976
• Product Code: MBH
• UDI-Device Identifier: 00889024469372
• UDI-Public: (01)00889024469372(17)290726(10)66682443
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: Lay User/Patient
• Device Catalogue Number: 42512100910
• Device Lot Number: 66682443
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 104 KG