MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522100810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 42502206802 - femur trabecular metal cruciate retaining (cr) narrow porous - 65100637 42530007102 - tibia trabecular metal two-peg porous fixed bearing right size e - 65561692 customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial right knee surgery.Approximately 3 years post-op, the patient is still experiencing pain.Imaging did not reveal any issues with the implant.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a6; b4; b5; b7; d2; g1; g3; g6; h1; h2; h10.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b7; d2; g1; g3; g6; h1; h2; h6.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was further reported that approximately 20 months post-op, the patient was diagnosed with synovitis and treated with nsaids and activity as tolerated.Attempts have been made and all available 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; h4; h6.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 and radiographs were provided and reviewed by a health care professional.Review of the available records identified that the patient continued to have pain while standing, rom: 0-120°, and was prescribed gabapentin.Imaging showed good alignment with minimal marrow edema in the distal femur and proximal tibia around the hardware which may reflect ongoing bone healing or minimal residual stress related/reactive marrow change secondary to prior arthritic change.Moderate suprapatellar effusion and mild prominence and internal heterogeneity of the popliteal vein were also seen that could reflect flow related artifact.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 ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHT
• 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: 23072658
• Report Number: 3007963827-2025-00367
• Device Sequence Number: 11958687
• Product Code: MBH
• UDI-Device Identifier: 00889024468412
• UDI-Public: (01)00889024468412(17)270622(10)65367533
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/06/2026

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: 42522100810
• Device Lot Number: 65367533
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 10/27/2025; 01/06/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/10/2025; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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
• Patient Weight: 109 KG
• Patient Race: White