MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CR ILOK FEM-LT 70 PROSTHESIS KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 01/18/2021

Event Type  Injury  

Event Description

It was reported patient had a manipulation under anesthesia due to limited range of motion and stiffness in knee forty eight days post implantation. Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4). Concomitant medical products - medical products: vngd ant stab brg 13x75 catalog # 189083 lot # 552740, biomet cc i-beam tray 75mm catalog # 141224 lot # j6785147. Customer has indicated that the product will not be returned because it remains implanted. Multiple mdr reports were filled for this event: (b)(4). According to tabers medical dictionary ¿ 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). Per clinical orthopaedics and related research (how to treat the stiff total knee arthroplasty? a systematic review), 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. 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: VANGUARD CR ILOK FEM-LT 70
• Type of Device: 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: 13694374
• Report Number: 0001825034-2022-00467
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 00880304270534
• UDI-Public: (01)00880304270534(17)300902(10)J6858698
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 183032
• Device Lot Number: J6858698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White
• Patient Outcome(s): Required Intervention; Hospitalization