MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN MEDIUM 22.5MM THICKNESS CEMENTED AUGMENTATION PATELLA; PROSTHESIS, KNEE

Catalog Number 00587601022

Device Problem Fracture (1260)

Patient Problems Necrosis (1971); Pain (1994)

Event Date 02/22/2024

Event Type  Injury  

Event Description

It was reported that patient underwent an initial total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient underwent revision surgery due to avascular necrosis fracture of the patella.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).D10: medical product: unknown femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni g2: foreign: australia the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent an initial total knee arthroplasty on an unknown date.On an unknown timeframe post-implantation, the patient began to experience pain and subsequently underwent revision surgery due to avascular necrosis fracture of the patella.Due diligence is complete as multiple attempts have been made; all available information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: NEXGEN MEDIUM 22.5MM THICKNESS CEMENTED AUGMENTATION PATELLA
• 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: 18934209
• MDR Text Key: 338033807
• Report Number: 0001822565-2024-00935
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024309654
• UDI-Public: (01)00889024309654(17)280508(10)65846726
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K004013
• 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,Followup
• Report Date: 04/11/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00587601022
• Device Lot Number: 65846726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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 H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose