MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Implant subsidence (4078)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial tka.Approximately two months postoperatively, the patient experienced a fall.This incident was initially managed with unknown conservative measures, but symptoms of pain gradually escalated over time.Within roughly three years of the index procedure, clinical evaluation and imaging revealed subsidence and loosening of the tibial component.This prompted a revision procedure.During the revision, the tibial baseplate was found to be grossly loose and was removed.The implant itself showed almost no cement adherence, while the entirety of the cement remained within the tibial bone cavity.Upon inspection, the cement was noted to be fractured, and the polyethylene insert exhibited no signs of wear.All available information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign: australia.D10: unknown, femoral component, unknown lot: 42532007102, articular surface, lot: 65368012, unknown, cement, unknown lot.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h6.Section d4 was corrected from may 8 to may 28, 2032.The event is confirmed.Visual examination of the provided photographs identified a tibial component covered in bio-debris.Visual examination of the returned tibial component identified signs of use (scratches on distal and proximal sides of the tibial plate).Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.- radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: radiograph dated (b)(6) 2023.¿ right knee arthroplasty, tibial component approximately three degrees varus alignment.¿ a paucity of cement present at the tibial plate bone interfaces.¿ radiolucency at tibial plate metal-bone and cement-bone interfaces of concern for tibial tray loosening.Generalized osteopenia noted.Radiograph dated (b)(6) 2025.¿ progressive radiolucencies at tibial component metal-bone and cement-bone interfaces, now also seen about the tibial stem, consistent with progressive loosening of the tibial component.Radiograph dated (b)(6) 2025.¿ coronal and sagittal ct images confirm radiolucent lines at tibial component metal-bone and cement-bone interfaces, consistent with loosening.¿ the tibial component demonstrates varus alignment increased compared with baseline, suggesting subsidence.¿ on the sagittal view, soft tissue opacity anterior to the distal femur in the expected region of the pre-femoral fat pad suggests possible pseudotumor or other mass.Details of the femoral component are limited by lack of lateral x-rays and limited visualization on 2 ct images.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 TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E
• 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: 22494220
• Report Number: 3007963827-2025-00277
• Device Sequence Number: 17211549
• Product Code: MBH
• UDI-Device Identifier: 00889024246706
• UDI-Public: (01)00889024246706(17)320528(10)65368012
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 10/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007102
• Device Lot Number: 65368012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 76 KG