MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN SIZE 5 PRECOAT CEMENTED STEMMED A/P WEDGED TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a left knee revision of the tibial tray approximately two years post-implantation for an unknown reason.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).B3 event date: unknown date in (b)(6) 2020.D6b explant date: unknown date in (b)(6) 2020.D10 therapy date: unknown date in (b)(6) 2020.D10 medical devices: femoral augment block distal only precoat size e 15 mm augment with screw catalog#: 00599003523 lot#: 63384845.Femoral augment block distal only precoat size e 15 mm augment with screw catalog#: 00599003523 lot#: 63384845.Articular surface size ef 12 mm height catalog#: 00596404012 lot#: 63313476.13mm diameter 100mm length straight stem extension combined length 145mm catalog#: 00598801013 lot#: 64007971.Long 14mm diameter 155mm length straight stem extension combined length 200mm catalog#: 00598801114 lot#: 64095180.Left size e cemented option femoral component femoral catalog#: 00599401591 lot#: 64003233 unknown palacos cement catalog#: ni lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h11.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN SIZE 5 PRECOAT CEMENTED STEMMED A/P WEDGED TIBIAL COMPONENT
• 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: 19976070
• Report Number: 0001822565-2024-02639
• Device Sequence Number: 17911119
• Product Code: JWH
• UDI-Device Identifier: 00889024220454
• UDI-Public: (01)00889024220454(17)271231(10)63814255
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598800500
• Device Lot Number: 63814255
• 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: 07/19/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2017
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 109 KG