MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 8; PROSTHESIS, KNEE

Catalog Number	42502006401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Necrosis (1971); Pain (1994); Muscle/Tendon Damage (4532)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: concomitant devices: 42512200510 - articular surface - 65279329; 42532007101 - tibial component - 65516816; 42540000035 - patella - 65750440; 110035368 - biomet bc r cement - ax26ae0210.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient had an initial bilateral knee arthroplasty.The patient reports chronic issues with both knees including pan and swelling.The patient had an mri with findings of bone necrosis, quadriceps and patella tendinosis, patellar tendon perforation, and moderate effusion.The devices remain implanted at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h4; h6; h10; h11 h6: component code: mechanical (g04) - femur 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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient reported experiencing persistent, bilateral leg issues since undergoing surgery, characterized by sensations of pulling, tightness, and pressure in the muscles, ligaments, and tendons, extending from the hips through the feet, predominantly around the knees.These sensations resemble the constriction of an inflated blood pressure cuff.Additionally, the patient noted pain in both knees, especially during activities like climbing stairs or driving, accompanied by swelling above the kneecaps.Despite consultations with various healthcare providers¿including a surgeon, general physician, and sports and exercise physician¿and adherence to prescribed physical therapy regimens, no definitive cause for these symptoms has been identified.The patient maintains a healthy lifestyle, engaging in regular low impact exercises and therapies such as massage, acupuncture, and red light therapy, though these have provided no lasting relief.An mri revealed a bone infarct in the distal femur, distal quadriceps tendinosis, patellar tendinosis with a full thickness perforation, and moderate joint effusion.A subsequent mri showed stable bone infarct size with improved surrounding bone marrow edema, a small knee effusion, and mild chronic patellar tendinosis, indicating some improvement compared to the previous study.A definitive root cause cannot be determined.This complaint can be confirmed based on the medical records provided.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 FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT SIZE 8
• 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: 21245604
• Report Number: 3007963827-2025-00027
• Device Sequence Number: 19739794
• Product Code: MBH
• UDI-Device Identifier: 00889024229938
• UDI-Public: (01)00889024229938(17)321206(10)65567264
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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 Catalogue Number: 42502006401
• Device Lot Number: 65567264
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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: Other
• Patient Sex: Female
• Patient Weight: 59 KG