MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD M PARTIAL KNEE MONOBLOCK TIBIAL TRAY B5 RM/LL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Loss of Range of Motion (2032)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - concomitant devices - oxford twin-peg cemented femoral component small catalog #: 161468 lot #: 726180 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 device history records were not reviewed as the reported event was procedure-related.The root cause of the reported event is determined to be unrelated to the implanted zimmer biomet device.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.

Event Description

It was reported that the patient underwent a right knee manipulation under anesthesia to treat stiffness and limited range of motion approximately three (3) months following right unicompartmental knee arthroplasty.No additional information is available.

• Brand Name: VANGUARD M PARTIAL KNEE MONOBLOCK TIBIAL TRAY B5 RM/LL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17916778
• MDR Text Key: 325444270
• Report Number: 0001825034-2023-02314
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00880304180642
• UDI-Public: (01)00880304180642(17)230809(10)832210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2023
• Device Model Number: N/A
• Device Catalogue Number: US154703
• Device Lot Number: 632210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2018
• 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 Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 75 KG