MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLUTED STEM EXTENSION STRAIGHT 9 MM DIAMETER 130 MM; PROSTHESIS, KNEE

Catalog Number	00585205009
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).D10: medical product: distal femoral xt component size b: catalog#00585004201, lot#65802262; polyethylene insert xt size b: catalog#00585001296, lot#65737438; 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: 0001822565-2024-00398; 0001822565-2024-00402.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: distal femoral xt component size b: catalog # 00585004201, lot # 65802262; polyethylene insert xt size b use with distal femoral xt size b: catalog # 00585001296, lot # 65737438; 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 #6 4796913; articular surface with segmental hinge post size b 26 mm height: catalog # 00585002026, lo t# 63530804.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures shows a femoral and poly that has been removed.A tab from the bottom of the metal femur can be seen to be broken off.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was unable to be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: FLUTED STEM EXTENSION STRAIGHT 9 MM DIAMETER 130 MM
• Common Device Name: 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: 18650979
• Report Number: 0001822565-2024-00403
• Device Sequence Number: 4513185
• Product Code: LZO
• UDI-Device Identifier: 00889024197701
• UDI-Public: (01)00889024197701(17)310724(10)65185229
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00585205009
• Device Lot Number: 65185229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/20/2024; 05/30/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/19/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female