MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA 0° KEEL LEFT SIZE D CEMENTED TIBIA; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed deep vein thrombosis accompanied by pain and lower leg swelling approximately one (1) week following left knee arthroplasty.The patient stayed overnight at the hospital and treated with eliquis while inpatient and was prescribed xarelto when released.The patient appeared to be improving when seen two (2) weeks later.Attempts have been made, however, no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona standard posterior stabilized femoral component left size 6 catalog #: 42500606001 lot #: 66612697, persona posterior stabilized articular surface left 12mm catalog #: 42512600512 lot #: 66684075, persona cemented all poly patella 32mm catalog #: 42540000032 lot #: 66898869.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.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 following sections were updated: b4, b5, b6, b7, g3, g6, h2, h6, h11.
Event or Problem Description
It was reported that the patient developed deep vein thrombosis (dvt) accompanied by pain and lower leg swelling approximately one (1) week following left knee arthroplasty.The patient decided to stay overnight at the hospital and was treated with an anticoagulant while inpatient and was then released the following day.The patient appeared to be improving when seen two (2) weeks later.Initial operative notes noted no intraoperative complications and the patient was sent to recovery in stable condition.Attempts have been made, however, no additional information is available.
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, h6, h11.Medical records provided confirmed the reported event.The device history records were not reviewed as the event was determined to be unrelated to the implanted device.Procedure-related complications are influenced by the type of surgery, patients' pre-existing comorbidities, and perioperative management.Deep vein thrombosis (dvt) occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operatively to prevent dvt formation.Even with the administration of preventive medication, dvts can still develop.Popliteal cyst (baker's cyst) is a common complication post knee replacement, but can also be caused by other problems such as arthritis.Popliteal cysts are formed from excessive synovial fluid produced post-operatively that causes the fluid to collect in a lump at the back of the knee.This varies in size and can cause pressure at the back of the knee, pain with bending or extending the joint, tightness and limited range of motion.Medical intervention of draining the cyst, therapy, medication, or any combination can be used to resolve the cyst.The complaint indicates that the patient developed post-operative complications and medical intervention was used for treatment.The root cause was determined to be traced to non-device related factors.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 0° KEEL LEFT SIZE D CEMENTED TIBIA
• 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: 21055636
• Report Number: 0001822565-2025-00008
• Device Sequence Number: 18180976
• Product Code: JWH
• UDI-Device Identifier: 00889024632080
• UDI-Public: (01)00889024632080(17)321216(10)65635671
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K221479
• 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,Followup
• Report Date (Section B): 04/07/2025

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: 42536006701
• Device Lot Number: 65635671
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 04/02/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/04/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2022
• 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: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American