MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA POSTERIOR STABILIZED STANDARD FEMUR LEFT SIZE 7; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - persona posterior stabilized articular surface left 10mm catalog #: 42511400710 lot #: 66557252.Persona spiked keel osseoti tibial tray left size e catalog #: 42535007101 lot #: 66151889.Persona cemented all poly patella 32mm catalog #: 42540000032 lot #: 66623263.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices remain implanted.The device history records were not reviewed as the reported event was determined to be unrelated to zimmer biomet devices.Bursitis is the inflammation or irritation of the bursae (fluid filled sac that cushions the joint) and is typically caused by repetitive motion, overuse, and pressure to the bursae.Bursitis is a very common condition that can impact any of the joints and can last for a short duration or years.Symptoms the patient can experience include pain, tenderness, swelling, stiffness, decrease in movement, and/or redness at or around the joint that is involved.Conservative treatment consists of over the counter (otc) medications, pain relievers, and anti-inflammatories, rest, ice, elevation, and applying pressure wraps.If conservative treatments fail, physical therapy, aspiration, arthroscopy, or steroid injections may be necessary.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure-related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.The root cause of the reported event was determined to be related to the procedure rather than zimmer biomet devices.
Event or Problem Description
It was reported that the patient experienced limited range of motion and stiffness a little over one (1) month following left knee arthroplasty.The patient was prescribed naproxen to treat pes bursitis and underwent a manipulation under anesthesia to treat arthrofibrosis.Initial operative notes noted no intraoperative complications.Manipulation notes noted no complications.

• Brand Name: PERSONA POSTERIOR STABILIZED STANDARD FEMUR LEFT SIZE 7
• 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: 20517985
• Report Number: 0001822565-2024-03354
• Device Sequence Number: 8701537
• Product Code: JWH
• UDI-Device Identifier: 00889024631717
• UDI-Public: (01)00889024631717(17)331010(10)66152692
• 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): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: 42506606201
• Device Lot Number: 66152692
• 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: 10/02/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White