MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 3; PROSTHESIS, KNEE

Catalog Number	00598603701
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that a patient underwent an initial left total knee arthroplasty.Approximately two (2) years and four (4) months post-implantation, the patient underwent revision surgery, due to aseptic loosening.Due diligence is in progress for this event.To date, no further information has been reported.
Additional Manufacturer Narrative
(b)(4).D10: medical product: nexgen femoral component size e left: catalog#: 00576401551, lot#: 64929174; articular surface size ef 10 mm height: catalog#: 00596203210, lot#: 64178214; all poly petella standard cemented, size 32 mm diameter 8.5 mm thickness: catalog#: 00597206532, lot#: 64833099; cobalt g-hv bone cement 40g: catalog#: 600-15-100, lot#: 105c1d004, qty#2.Multiple mdr reports have been filed for this event.Please see associated reports: 3007963827-2024-00070.Customer has indicated, that the product will not be returned to zimmer biomet for investigation, per hospital policy.The investigation is in process.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.Upon receipt of additional information, this device was determined to be not reportable.Correspondence indicated that the tibial component remained well fixed and did not exhibit loosening that led to revision surgery of the patient.The previously reported device did not cause or contribute to the reported event.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
Upon receipt of additional information, this device was determined to be not reportable.Correspondence indicated that the tibial component remained well fixed and did not exhibit loosening that led to revision surgery of the patient.The previously reported device did not cause or contribute to the reported event.

• Brand Name: NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT SIZE 3
• 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: 18891074
• Report Number: 0001822565-2024-00871
• Device Sequence Number: 15329692
• Product Code: JWH
• UDI-Device Identifier: 00889024218833
• UDI-Public: (01)00889024218833(17)300514(10)J6782081
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00598603701
• Device Lot Number: J6782081
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2020
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female