MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED RIGHT SIZE E STEM EXTENSION USE REQUIRED; 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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/20/2020
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.Concomitant medical products: 42540000032, all poly patella cemented 32 mm diameter, lot 64620959, 42560007514, stem extension tapered cemented 14 mm diameter +75 mm length, lot 64783462, 42504606602, femur cemented standard right size 9, lot 64705415, 42560007514, stem extension tapered cemented 14 mm diameter +75 mm length, lot 64783462, multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2022 - 00035, 0001822565 - 2022 - 00460, 0001822565 - 2022 - 00461, 0001822565 - 2022 - 00462, 0001822565 - 2022 - 00463.
Event or Problem Description
It was reported that approximately three days post implantation, the patient had presented to the emergency department with complaints of pain.During evaluation, the surgeon noted hemarthrosis of the replaced joint.Patient was treated with physical therapy and a narcotic pain medication.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
Upon review and medical investigation of this event, it has been determined that this event does not meet the requirements of a complaint.Pain on postoperative day 1 is not considered an abnormal finding, as most patients are kept minimal of 1 day in the hospital for pain management.It is now known that the patient underwent an outpatient surgery and was released to go home postoperatively.The patient was unable to manage their pain and was instructed to go to the emergency room.No abnormal findings were noted in the emergency visit; only provided serial pain medication to achieve pain control.Follow up visit on postoperative day 3 with the surgeon recommended supportive device, such as knee mobilizer and increased patient oral pain medication.Surgeon also noted mild hemarthrosis and no surgical intervention provided.Follow up visits noted pain and hemarthrosis resolved, devices remain implanted.The initial report for this event should be considered voided.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 or Problem Description
See h10 narrative.

• Brand Name: TIBIA FIXED CEMENTED RIGHT SIZE E STEM EXTENSION USE REQUIRED
• 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: 13568865
• Report Number: 0001822565-2022-00464
• Device Sequence Number: 11791915
• Product Code: JWH
• UDI-Device Identifier: 00889024562882
• UDI-Public: (01)00889024562882(17)290831(10)64454891
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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 Model Number: N/A
• Device Catalogue Number: 42542007102
• Device Lot Number: 64454891
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 99 KG