MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE SIZE CD 10 MM HEIGHT "USE WITH PLATE 1; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10: 00598002702 - stemmed tibial component precoat size 2 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 65914855.G2: foreign - china.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the liner cannot assemble to the tibial tray.A back-up was used to complete the surgery.There was no consequences or impact to the patient.

• Brand Name: ARTICULAR SURFACE SIZE CD 10 MM HEIGHT "USE WITH PLATE 1
• 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: 19059341
• MDR Text Key: 339589783
• Report Number: 0001822565-2024-01174
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024634718
• UDI-Public: (01)00889024634718(17)271211(10)65778459
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173057
• 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: 04/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596402210
• Device Lot Number: 65778459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2022
• 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