MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE EF 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00104.Implant date: unknown date in (b)(6) 2011.Concomitant medical products: medical devices: femoral component option size e left catalog#: 00576401551; lot#: 64717255.All poly patella standard cemented size 32 mm diameter 8.5 mm thickness catalog#: 00597206532; lot#: 64774902.Unknown tibial tray catalog#: ni lot#: ni.Unknown palacos cement catalog#: ni lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it 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 the patient underwent a left knee manipulation under anesthesia approximately three months post-implantation to increase range of motion.The patient reports still experiencing pain, swelling, and insufficient range of motion, necessitating continued trips to physical therapy.No revision procedure has been reported.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A manipulation under anesthesia was performed in (b)(6) 2021 following an initial left total knee arthroplasty in (b)(6) 2021 for decreased range of motion.Manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.With anesthesia is (mua).Mua is used to treat and resolve arthrofibrosis (scar tissue).This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis.The indication for manipulation under anesthesia is related to limited range of motion and stiffness due to adhesions/scar tissue.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE SIZE EF 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14205695
• Report Number: 0001822565-2022-01174
• Device Sequence Number: 1803834
• Product Code: JWH
• UDI-Device Identifier: 00889024211131
• UDI-Public: (01)00889024211131(17)250131(10)64644398
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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 Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00596203210
• Device Lot Number: 64644398
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown