MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RIGHT 11MM SIZE 8-11 EF; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994); Insufficient Information (4580)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision of the articular surface to address unknown complications approximately three (3) years post-operatively.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - unknown persona femoral component catalog #: ni lot #: ni, unknown persona tibial component catalog #: ni lot #: ni.G2: foreign - event occurred in australia.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a3, b4, b5, d10, g3, g6, h2, h3, h4, h6, h11.D10 - concomitant devices - persona cemented stemmed tibial component right size f catalog #: 42532007502 lot #: 65553363, persona cruciate retaining standard femoral component right size 10 catalog #: 42502606802 lot #: 65486807 the reported event could not be confirmed as medical records were not provided.The device history records were not reviewed as the event was determined to be unrelated to the implanted device.Disease progression of osteoarthritis can continue in native bone structures as a patient continues to age.Other patient comorbidities, lifestyle, physical activities and some medications can increase the patient's risk for progressive osteoarthritis, with females having an inherent risk.Partial knee replacements are performed to decrease pain and increase flexibility, mobility and overall improve quality of life while being a less invasive approach.However, patients with disease progression of osteoarthritis in the affected joint develop knee pain and decrease in joint flexibility and as osteoarthritis progresses, a loss of cartilage in the previously unaffected area of the knee can deteriorate to a point in which the patient may be advised to convert to a full knee replacement to alleviate symptoms.The root cause was determined to be unrelated to the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent a knee arthroplasty revision of the articular surface and patellar resurfacing to address anterior knee pain secondary to progression of osteoarthritis approximately three (3) years post-operatively.Attempts have been made, however, no additional information is available.

• Brand Name: PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RIGHT 11MM SIZE 8-11 EF
• 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: 24345651
• Report Number: 3007963827-2026-00059
• Device Sequence Number: 18560511
• Product Code: MBH
• UDI-Device Identifier: 00889024468429
• UDI-Public: (01)00889024468429(17)271001(10)65545206
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• 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): 04/07/2026

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 Model Number: N/A
• Device Catalogue Number: 42522100811
• Device Lot Number: 65545206
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male