MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN TRABECULAR METAL CR MONOBLOCK TIBIAL COMPONENT: YELLOW, SIZE 3 C-H, 12MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that tech noticed a hole in the packaging when the implant was opened.Another implant was used to complete the surgery.

• Brand Name: NEXGEN TRABECULAR METAL CR MONOBLOCK TIBIAL COMPONENT: YELLOW, SIZE 3 C-H, 12MM
• 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: 19191284
• MDR Text Key: 341146506
• Report Number: 0001822565-2024-01418
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024310018
• UDI-Public: (01)00889024310018(17)260505(10)64983244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2024

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: 00588604312
• Device Lot Number: 64983244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2021
• 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