MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD NITRIDED LEFT SIZE 5; 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	01/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: articular surface fixed bearing posterior stabilized (ps) left 13 mm height: catalog#: 42511400413, lot#: 63016558; tibia cemented 5 degree stemmed left size c: catalog#: 42532006401, lot#: 65282117; all poly patella cemented 29 mm diameter: catalog#:42540000029, lot#65593945; stem extension tapered cemented 14 mm diameter +30 mm length: catalog#: 42557000114, lot#: 65561975; unknown stryker bone cement: catalog#: ni, lot#: ni.Multiple mdr reports have been filed for this event.Please see associated report: 0002648920-2023-00010.A review of the device history records was not performed as the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported via a clinical study that a patient underwent an initial left total knee arthroplasty.Subsequently, approximately two months post-implantation, the patient experienced limited range of motion due to fibrosis and underwent a manipulation under anesthesia procedure.The procedure was completed without complication.

• Brand Name: FEMUR CEMENTED POSTERIOR STABILIZED (PS) STANDARD NITRIDED LEFT SIZE 5
• 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: 16327000
• Report Number: 0001822565-2023-00335
• Device Sequence Number: 8583377
• Product Code: JWH
• UDI-Device Identifier: 00889024576476
• UDI-Public: (01)00889024576476(17)301118(10)64945377
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K200209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 02/08/2023

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: 42570605801
• Device Lot Number: 64945377
• 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: 01/20/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White