MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522100411
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); Scar Tissue (2060); Swelling/ Edema (4577)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately five (5) months post-implantation, the patient began to experience progressive stiffness, swelling, pain, and range of motion limitations.Subsequently, the patient underwent revision surgery where the surgeon excised abundant scar tissue, exchanged the polyethylene bearing for a smaller size, and implanted an initial patella component due to arthritic changes in the patellar bone.The tibial and femoral components were well fixed and remained intact.
Additional Manufacturer Narrative
(b)(4).D10: medical product: femur cemented cruciate retaining (cr) standard right size 6: catalog#42502606002, lot#64792396; tibia cemented 5 degree stemmed right size d: catalog#42532006702, lot#65077973; hi-fatigue bone cement 2x40 r: catalog#00112024001, lot#19ca17440.G2: foreign: italy.The product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.Operative notes provided and reviewed state that the patient underwent an initial right total knee arthroplasty (tka) on (b)(6) 2021 using rosa guidance due to osteoarthritis.Five (5) months post-op, the patient was revised due to progressive stiffness, swelling, and limited range of motion (0¿45 deg).Intraoperatively, abundant scar tissue was excised.The original articular surface was replaced with a thinner insert, and a patellar component was implanted due to observed arthritic changes in the patella.The femoral and tibial components remained well-fixed and were retained.Patellar tracking was noted as good, and there were no intraoperative complications.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records.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 ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 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 ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21687690
• Report Number: 3007963827-2025-00109
• Device Sequence Number: 8849643
• Product Code: MBH
• UDI-Device Identifier: 00889024468108
• UDI-Public: (01)00889024468108(17)260403(10)64989680
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 04/08/2025

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 Expiration Date: 04/03/2026
• Device Catalogue Number: 42522100411
• Device Lot Number: 64989680
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 84 KG