MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL XT COMPONENT SIZE B LEFT; PROSTHESIS, KNEE

Catalog Number 00585004201

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a left total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post-implantation, the patient underwent revision surgery as the femoral component had disassociated from the femoral stem.The rotation tabs on the femoral component were also found to be fractured.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).Medical product: polyethylene insert xt size b: catalog#00585001296, lot#65737438; unknown femoral stem extension: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2024-00402; 0001822565-2024-00403.Customer has indicated that the product will not be returned to zimmer biomet for evaluation per hospital policy.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a left total knee arthroplasty.Subsequently, three months post-implantation, the patient tried to get up and felt the knee break.The patient underwent revision surgery and it was revealed that the femoral component had fractured and disassociated from the femoral stem.The distal femoral component, poly box and articular surface were replaced without reported complication.Due diligence is complete as multiple attempts have been made however all available information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: medical product: polyethylene insert xt size b use with distal femoral xt size b: catalog#00585001296, lot#65737438; fluted stem extension straight precoat 9 mm diameter 130 mm length: catalog#00585205009, lot#65185229; stem collar 30 mm: catalog#00585204030, lot#65271410; size 3 precoat cemented tibial component: catalog#00588000300, lot#64981949; trabecular metal tibial half block augment tapered left lateral: catalog#00544800340, lot#65059447; trabecular metal tibial half block augment tapered left medial: catalog#00544800330, lot#64149199; 11mm diameter 100mm length straight stem extension combined length 145mm: catalog#00598801011, lot#64796913; articular surface with segmental hinge post size b 26 mm height: catalog#00585002026, lot#63530804.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: DISTAL FEMORAL XT COMPONENT SIZE B LEFT
• 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: 18650977
• MDR Text Key: 334659095
• Report Number: 0001822565-2024-00398
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150028
• 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,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00585004201
• Device Lot Number: 65802262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female