MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR TRABECULAR METAL POSTERIOR STABILIZED; PROSTHESIS, KNEE

Catalog Number	42500805802
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); Joint Laxity (4526)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: unknown - unknown articular surface - unknown.Unknown - unknown tibial component - unknown.G2: foreign country: united kingdom.H6: mechanical (g04) - femur.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.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately 1 year post-op, the patient underwent an arthroscopy and manipulation due to pain, poor range of motion, and stiffness.A steroid injection in the it band also provided temporary relief, however, the patient continued to report instability in flexion and hypermobility.Subsequently, the patient was revised approximately 2.5 years post-op.Attempts have been made and all available information has been provided.
Event or Problem Description
It was reported from an external clinical study that a patient underwent an initial right total knee arthroplasty without patellar replacement.Subsequently, the patient underwent an arthroscopy approximately 10 months post-op due to pain, poor range of motion, and stiffness.During the exam, full range of motion was achieved with no need for a manipulation.The knee was stable in full extension, but some laxity was observed in flexion.A steroid injection in the it band provided temporary relief; however, the patient later reported continued instability in flexion and the knee was successfully revised approximately 2.5 years post-op.During the revision, the preop exam under anesthesia revealed restriction to full extension with mid flexion instability and increased laxity in full flexion.The tibial and femoral implants were found well fixed and in good condition.Grade iii osteoarthritic changes were observed on the native patella with a large hooked osteophyte removed prior to resurfacing.All implants were exchanged, and a patellar button was implanted without complications.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; d1; d2; d4; d10; e1; g1; g3; g4; g6; h1; h2; h4; h6.D10: 42521400413 - articular surface fixed bearing posterior stabilized (ps) right 13 mm height - 65625929.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; d2; g1; g3; g6; h1; h2; h3; h6; h10 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.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: participant suffered from stiffness and poor rom and subsequently underwent a mua.At the time of the mua, the participant underwent an arthroscopy to obtain samples.No indication of infection or loosening to account for participants pain and stiffness symptoms.Participant had a steroid injection into it band which provided 2 weeks of relief from symptoms.Ct and bone scans of knee was normal yet suggest the implant had 1° of internal rotation of the femur, and 3° of internal rotation of the tibia.Implant sizing looked satisfactory.Patient described that they felt unstable in flexion and may have hyper mobility.Decision was made to revise tka.Eua found full rom with no manipulation required.Knee stable in full extension ¿ at 20 degree flexion, definite medio-lateral laxity felt ¿ about 3-4 mm.At 90 degrees, no obvious lift off appreciated.Attempts to replicate complaint of femoral lurching when extending knee while on side unable to produce any instability.Arthroscopy showed no abnormalities.Steroid injection given as planned for scar prophylaxis.Single stage revision tka was undertaken and was successful.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.

• Brand Name: PERSONA FEMUR TRABECULAR METAL POSTERIOR STABILIZED
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23926657
• Report Number: 0001822565-2025-04924
• Device Sequence Number: 9041403
• Product Code: MBH
• UDI-Device Identifier: 00889024469846
• UDI-Public: (01)00889024469846(17)290430(10)64317695
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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: 42500805802
• Device Lot Number: 64317695
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 03/31/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/21/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2019
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 82 KG