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

Catalog Number	42502606402
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Joint effusion (4849); Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Approximately 1 year post-op, the patient developed pain and effusion.Six aspirations have been performed with the latest resulting in 600 wbc and the patient was diagnosed with synovitis.X-ray showed femoral component loosening along with complaints of ambulation difficulties and joint laxity.Revision was recommended by surgeon.No further information provided at this time.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 42522100810 - articular surface medial congruent (mc) right 10 mm height use with tibia sizes e-f/cr femur sizes 8-11 - 64832517.42532007502 - tibia cemented 5 degree stemmed right size f - 64884847.42540200032 - all-poly patella cemented 32 mm diameter - 64825590.Unknown - unknown bone cement - unknown - unknown.G2: mechanical (g04) - femur.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.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 by review of medical records.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: the patient presented with recurrent bilateral knee pain, predominantly in the right knee, with repeated effusions and progressive functional decline.Despite multiple aspirations and treatments, effusions persisted without significant improvement.X-ray imaging revealed femoral loosening and clinically the patient experienced right knee instability, pain with weight bearing, and difficulty ambulating (requiring a cane) and a revision was recommended.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 CEMENTED CRUCIATE RETAINING (CR)
• 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: 22307403
• Report Number: 3007963827-2025-00253
• Device Sequence Number: 15629607
• Product Code: MBH
• UDI-Device Identifier: 00889024230385
• UDI-Public: (01)00889024230385(17)300929(10)64807962
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 42502606402
• Device Lot Number: 64807962
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2020
• 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 Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White