MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE G; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 medical devices: persona femur tm posterior stabilized (ps) standard porous catalog#: 42500806402 lot#: 65022787.Persona articular surface fixed bearing posterior stabilized (ps) right 11 mm height catalog#: 42522400911 lot#: 64442782.Persona all-poly patella cemented 35 mm diameter catalog#: 42540200035 lot#: 65095462.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Approximately one month later, the patient underwent manipulation under anesthesia for arthrofibrosis and stiffness.The implants remained intact.It was noted that the patient continues to have limited range of motion due to scar tissue/adhesions.Subsequently, approximately thirteen months from initial implantation, a mri indicated tibial subsidence and tibial loosening.No further interventions have been reported.
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.Updated: b4, g3, g6, h2, h3, h6, h10, and h11.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: right knee aspiration, pain, swelling, and arthrofibrosis; right knee pain, arthrofibrosis, tibial subsidence, implant loosening; following mri: ambulates with antalgic gait, rom is 5 short of full extension to 95 degrees flexion.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA TIBIA TM TWO-PEG POROUS FIXED BEARING RIGHT SIZE G
• 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: 19645544
• Report Number: 0001822565-2024-02192
• Device Sequence Number: 18080371
• Product Code: MBH
• UDI-Device Identifier: 00889024510609
• UDI-Public: (01)00889024510609(17)310928(10)65115097
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K173417
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42530007902
• Device Lot Number: 65115097
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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 H10
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White