MAUDE Adverse Event Report: ZIMMER TMT NEXGEN COMPLETE KNEE SOLUTION, TRABECULAR METAL STANDARD PRIMARY PATELLA; 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	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device 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 that the initial left total knee arthroplasty performed.Subsequently, the patient underwent a manipulation under anesthesia approximately 8 weeks post procedure due to arthrofibrosis.At the following visit, the patient showed improved range of motion.
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.According to tabers medical dictionary ¿ manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint under anesthesia (mua) 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: NEXGEN COMPLETE KNEE SOLUTION, TRABECULAR METAL STANDARD PRIMARY PATELLA
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 12522496
• Report Number: 3005751028-2021-00057
• Device Sequence Number: 4584504
• Product Code: JWH
• UDI-Device Identifier: 00889024309814
• UDI-Public: (01)00889024309814(17)260511(10)64975771
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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 Expiration Date: 05/11/2026
• Device Model Number: N/A
• Device Catalogue Number: 00587806535
• Device Lot Number: 64975771
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 68