MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522100712
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: nexgen complete knee solution, trabecular metal standard primary patella: catalog#00587806535, lot#65160037; tibia trabecular metal two-peg porous fixed bearing right size e: catalog#42530007102, lot#65115127; femur trabecular metal cruciate retaining (cr) narrow porous: catalog#42502206202, lot#64900145; unknown cement: catalog#ni, lot#ni.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related 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: revision surgical notes: poly appeared to be thinner than necessary, poly needed to be thicker to address the recurvatum and mild laxity.New patella cemented into place, new polyethylene placed.Wound irrigated and closed in layers.No intraoperative complications reported.The reported event was confirmed by review of provided medical records.Root cause was unable to 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
It was reported that the patient underwent a right knee revision approximately 3 years and 3 months post-implantation due to patella button loosening.During the revision, moderate synovitis and scar tissue were removed.The polyethylene insert was noted to be thinner than necessary and a thicker insert was selected to address recurvatum and mild laxity.The undersurface of the patella was observed to be fractured, and the patella button and polyethylene insert were exchanged.The procedure was completed without complications.Attempts have been made and no further information has been provided.

• Brand Name: PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 12 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 ; 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: 25035839
• Report Number: 3007963827-2026-00155
• Device Sequence Number: 13286150
• Product Code: MBH
• UDI-Device Identifier: 00889024468351
• UDI-Public: (01)00889024468351(17)260604(10)65048429
• 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: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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 Expiration Date: 06/04/2026
• Device Catalogue Number: 42522100712
• Device Lot Number: 65048429
• 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: 09/02/2025
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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: Female
• Patient Weight: 115 KG