MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA TIBIA; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Bacterial Infection (1735); Hematoma (1884); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported a patient had an initial left total knee arthroplasty.Subsequently, the patient began experiencing pain and swelling and developed a hematoma.At a post-operative visit, the hematoma was lanced to improve stiffness and range of motion.Approximately 2 months post implantation, the patient underwent a knee aspiration with positive infection markers.Approximately 3 months later, the patient underwent a biopsy where staph crepitus and cutbacterium grew.Stage i of a two stage revision was completed 6 months post implantation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D6a: implant date: (b)(6) 2023.G2: foreign: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00733 and 0001822565-2024-00735.

• Brand Name: UNKNOWN PERSONA TIBIA
• 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: 18830587
• MDR Text Key: 336817869
• Report Number: 0001822565-2024-00734
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male