MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 0 DEGREE CEMENTED TIBIAL COMPONENT RIGHT SIZE F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a right knee arthroplasty revision to address tibial loosening approximately two (2) years post-operatively.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10: concomitant devices - persona medial congruent articular surface right 12mm size 6-7 ef catalog #: 42522100712 lot #: 65424753, persona cruciate retaining standard femoral component size 7 r catalog #: 42508606202 lot #: 66073893, nexgen porous tm patella 10mm x 35mm catalog #: 00587806535 lot #: 66068247.The complainant has indicated that the product will not be returned to zimmer biomet for investigation as the patient kept the explanted device.The investigation is in process.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 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 not provided.The root cause is attributed to a failure to follow instructions for not using cement with the implant.Per the instructions for use, ''porous coated components may be used cemented or uncemented (biological fixation), except for the persona osseoti keel tibia which is for uncemented use only.All other femoral, tibial baseplate and all-polyethylene (uhmwpe and vehxpe) patella components are indicated for cemented use only.'' a porous coated component was not implanted.Therefore, cement should have been used.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 0 DEGREE CEMENTED TIBIAL COMPONENT RIGHT SIZE F
• 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: 21526099
• Report Number: 0001822565-2025-00536
• Device Sequence Number: 15567171
• Product Code: JWH
• UDI-Device Identifier: 00889024632134
• UDI-Public: (01)00889024632134(17)330430(10)65805646
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: 42536007502
• Device Lot Number: 65805646
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Male