MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE EF 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 medical devices: nexgen femoral component option size f right catalog#: 00576401652 lot#: 63542297 nexgen stemmed nonaugmentable tibial component option cr/ps/lps size 5 catalog#: 00598604701 lot#: 63522901 nexgen all poly patella standard cemented size 32 mm diameter catalog#: 00597206532 lot#: 63530611.G2 foreign source: united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right total knee arthroplasty.Subsequently, the patient claims they require a revision procedure for an unknown reason.Attempts have been made and no further information has been provided.

• Brand Name: NEXGEN ARTICULAR SURFACE SIZE EF 10 MM HEIGHT
• 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: 19202027
• MDR Text Key: 341270849
• Report Number: 0001822565-2024-01425
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024211940
• UDI-Public: (01)00889024211940(17)241031(10)63504466
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/29/2024

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: 00596404010
• Device Lot Number: 63504466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2016
• 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
• Treatment: SEE H11
• Patient Outcome(s): Hospitalization; Required Intervention