MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TRABECULAR METAL CRUCIATE RETAINING NARROW POROUS FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona medial congruent articular surface left 10mm catalog #: 42512100810 lot #: 66560666, persona spiked keel osseoti tibia left size f catalog #: 42535007501 lot #: 66421904, persona osseoti porous 3-peg patella 32mm catalog #: 42540500032 lot #: 66634279.The complainant has indicated that the product will not be returned to zimmer biomet for investigation as the device 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 a left knee manipulation under anesthesia to address knee stiffness and limited range of motion approximately seven (7) weeks following left knee arthroplasty.No additional patient consequences were reported.Initial operative notes noted no intraoperative complications.Manipulation operative notes noted the patient's range of motion was 85 degrees preoperatively.Manipulation was performed successfully and the patient's range of motion was 125 degrees at the conclusion of the procedure.No intraoperative complications were noted.
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, g3, g6, h2, h3, h6, h11.H6 - component code - proposed code is mechanical (g04) femur.Medical records provided confirmed that the patient underwent a successful manipulation under anesthesia to address limited range of motion.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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 TRABECULAR METAL CRUCIATE RETAINING NARROW POROUS FEMORAL COMPONENT
• 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: 20320344
• Report Number: 0001822565-2024-03086
• Device Sequence Number: 18108479
• Product Code: MBH
• UDI-Device Identifier: 00889024470132
• UDI-Public: (01)00889024470132(17)311208(10)65098175
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/14/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502206801
• Device Lot Number: 65098175
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White