MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE SIZE BLUE 12MM; 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); Scar Tissue (2060)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - persona cruciate retaining standard femoral component right size 12, catalog #: 42502607402, lot #: 65082198.Nexgen cruciate retaining pegged precoat tibial component size 7, catalog #: 00597005501, lot #: 64203169.Nexgen standard all poly patella, catalog #: 00597206538, lot #: 64843612.Manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.Per clinical orthopaedics and related research, manipulation 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.The root cause is attributed to non-device related factors.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 3007963827-2022-00146, 0001822565-2022-01482.
Event or Problem Description
It was reported that the patient underwent a manipulation under anesthesia to address moderate pain and stiffness following a right knee arthroplasty.Initial operative notes noted the patient was experiencing pain, severe joint space narrowing, subchondral sclerosis, osteophytes and subchondral cysts prior to the procedure.No intraoperative complications were noted.Manipulation operative notes noted that the breaking up of scar tissue was audible and palpable.Post-operative range of motion was ten (10) to one hundred twenty (120) degrees.No complications were noted.

• Brand Name: NEXGEN CRUCIATE RETAINING ARTICULAR SURFACE SIZE BLUE 12MM
• 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: 14456988
• Report Number: 0001822565-2022-01482
• Device Sequence Number: 19975837
• Product Code: JWH
• UDI-Device Identifier: 00889024230460
• UDI-Public: (01)00889024230460(17)260531
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00597605012
• Device Lot Number: 64043324
• 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: 05/05/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White