MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN ALL POLY PETELLA STANDARD CEMENTED SIZE 35 MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Malposition of Device (2616); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 04/09/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 : 00588001601 - left size f cemented option femoral component femoral plastic cap must be removed prior to implantation - 63932973.00598801215 - 15mm diameter 30mm length straight stem extension combined length 75mm - 64732973.00588000500 - size 5 precoat cemented tibial component - 63847192.00598801015 - 15mm diameter 100mm length straight stem extension combined length 145mm - 64280968.00588006012 - 12mm height size f articular surface with hinge post extension / use with plate 5,6 / screw enclosed do not discard - 64174108.66022663 - palacos r + g (1x40) - 90614738.66022663 - palacos r + g (1x40) - 96124845.G2 : foreign country : australia.Customer has indicated that the product will not be 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 patient underwent an initial left total knee arthroplasty.Approximately 3.5 years later, they underwent a revision of the patella for noise, malalignment, and scar tissue.Attempts have been made and all available information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was further reported that the surgeon noted wear on the implant and that the patient was experiencing discomfort.This discomfort was described as pain.Attempts have been made and all available information has been provided.

• Brand Name: NEXGEN ALL POLY PETELLA STANDARD CEMENTED SIZE 35 MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19172895
• MDR Text Key: 340926653
• Report Number: 0002648920-2024-00117
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024635395
• UDI-Public: (01)00889024635395(17)280229(10)64620677
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 05/09/2024

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 Model Number: N/A
• Device Catalogue Number: 00597206535
• Device Lot Number: 64620677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/05/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2020
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 71 KG