MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA FIXED CEMENTED LEFT SIZE D STEM EXTENSION USE REQUIRED; PROSTHESIS, KNEE

Catalog Number	42542006701
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Osteopenia/ Osteoporosis (2651); Bursitis (4832); Joint effusion (4849); Aseptic loosening (4883); Tendinopathy (4887)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study that underwent a total knee procedure.Subsequently, two (2) years and five (5) months post-implantation, the patient reported severe pain and a concern of weakness.Ongoing tendinitis/bursitis and mild effusion were also noted on exam.On the next follow-up six (6) months later, radiographic imaging displayed possible loosening and bone loss.The patient wishes to manage these symptoms conservatively with home care and observation at this time.All components remain implanted.No further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: medical product: persona revision fem cmt ccr pls sz 7l: catalog#42504606211, lot#64900906; persona revision str spln stem 16x135: catalog#42560113516, lot#64853724; persona stem extension straight splined uncemented 15 mm diameter +135 mm length: catalog#42560113515, lot#65042462; persona articular surface fixed bearing constrained posterior stabilized (cps) left 16 mm height: catalog#42512600516, lot#64099963; unknown stryker cement: catalog#ni, lot#ni.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d10; g3; h2; h3; h4; h6; h10; h11.D10: medical product: stem extension straight splined uncemented 15 mm diameter +135 mm length: catalog#42560113515, lot#65042452.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.Regarding the reported pain, root cause was unable to be determined.Regarding the reported tendonitis and bursitis, the root cause of the reported event was determined to be not related to the device.Bursitis is the inflammation or irritation of the bursae (the fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse, and pressure to the bursae.Bursitis is a very common condition that can impact any of the joints and can last for a short duration or years.Conservative treatment consists of over the counter (otc) medications pain relievers and anti-inflammatories, rest, ice, elevation, and applying pressure wraps.If conservative treatments fail, physical therapy, aspiration, arthroscopy, or steroid injections may be necessary.The complaint indicates that postop bursitis developed and required medical intervention for treatment.Tendonitis is the inflammation or irritation of the tendons and is typically caused by repetitive motion, overuse, and pressure to the bursae.Patients can experience a decrease in overall adls, rom of the joint, decrease in quality of life, as well as an increased need for possible over-the-counter (otc) medications for swelling and pain control.This condition can impact the patient's ability to use the joint fully, decrease overall activities of daily living (adls), range of motion (rom) of the joint, and quality of life, while increasing the need for possible over-the-counter (otc) medications for swelling and pain control.Treatment options include otc medications, prescribed pain medications, physical therapy, rest, ice, elevation of the affected joint, and steroid injections.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.

• Brand Name: PERSONA TIBIA FIXED CEMENTED LEFT SIZE D STEM EXTENSION USE REQUIRED
• 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: 22472140
• Report Number: 0001822565-2025-02455
• Device Sequence Number: 18106201
• Product Code: JWH
• UDI-Device Identifier: 00889024562783
• UDI-Public: (01)00889024562783(17)3107020(10)65069838
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: Lay User/Patient
• Device Catalogue Number: 42542006701
• Device Lot Number: 65069838
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White