MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 2.5 MM FEMALE HEX SCREW 25 MM LENGTH; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Malposition of Device (2616)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bacterial Infection (1735); Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360); Joint Contracture (4528); Joint effusion (4849)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient reports pain, intermittent swelling, and deformity since surgery and then began experiencing instability, and a flexion contracture.Radiographic imaging displayed lucency of the femoral component and patellar button and 12 degrees varus alignment of the tibial component.Approximately one year post implantation the patient underwent a revision for instability, arthrofibrosis, and malalignment.All components, except the patella, were revised without complication.During the surgery, cultures were taken and later, one of the cultures from the femoral membrane, grew evidence of propionibacterium acnes.The patient was placed on a three-month course of oral doxycycline.The patient has continued through the study without ongoing infection related complications.
Additional Manufacturer Narrative
(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs 42530008302 persona tibia trabecular metal two-peg porous fixed bearing rt size h lot# 64077392.Mdr: 0001822565-2024-00496.42502806602 persona femur trabecular metal cruciate retaining (cr) std porous lot# 64317789.Mdr: 0001822565-2024-00497.
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/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h10, h11.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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records/radiographs were provided and reviewed by a health care professional.The radiographs were not submitted as the findings/results were documented within the medical records.Review of the available records identified the following: patient presented with pain, swelling, mild effusion, instability and limited range of motion; radiolucency under femoral posterior condyles and anterior flange; tibial malalignment; intra-op culture positive for bacterial microbiology.This complaint has been confirmed by review of the provided medical records.A definitive root cause cannot be determined.No actions needed at this time.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 2.5 MM FEMALE HEX SCREW 25 MM LENGTH
• 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: 18924835
• Report Number: 0001822565-2024-00949
• Device Sequence Number: 4479289
• Product Code: HWD
• UDI-Device Identifier: 00889024232532
• UDI-Public: (01)00889024232532(17)291130(10)64591627
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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): 07/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42509902525
• Device Lot Number: 64591627
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White