MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN COMPLETE KNEE SOLUTION, TRABECULAR METAL STD PRI PATELLA; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 10/11/2019

Event Type  Injury  

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.  additional associated products 42502206402 persona femur trabecular metal (cr) narrow porous lot# 64278729 42530007102 persona tibia trabecular metal 2-peg porous fxd brg rt size e lot# 64077537 42522100810 persona articular surface medial congruent (mc) right 10 mm lot# 64375813.

Event Description

It was reported a patient began to experience limited range of motion, difficulty ambulating, pain, swelling, and stiffness about one month post implantation, underwent a manipulation under anesthesia.The scar tissue was easily released and the procedure was completed without complications.All implants remain in place.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

No further event information available at the time of this report.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION, TRABECULAR METAL STD PRI PATELLA
• Type of Device: 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: 19133109
• MDR Text Key: 340477914
• Report Number: 0001822565-2024-01295
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024309807
• UDI-Public: (01)00889024309807(17)240229(10)64227939
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• 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,Followup
• Report Date: 08/06/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 00587806532
• Device Lot Number: 64227939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 07/31/2024
• Supplement Dates FDA Received: 08/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H11 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White