MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING LEFT SIZE C; PROSTHESIS, KNEE

Model Number	42-5300-064-01
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/09/2022
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 years post-implantation, the patient underwent revision surgery of the tibial component and articular surface.The reason for revision surgery is unknown.Due diligence is in process for this complaint; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: articular surface medial congruent (mc) left 10 mm height: catalog#: 42512100310, lot#: 64666785; tm uncemented femoral component size 5 narrow cr: catalog#: ni, lot#: ni; unknown short stem extension: catalog#: ni, lot#: ni; unknown 29mm poly patella: catalog#: ni, lot#: ni.Report source: foreign: australia.Multiple mdr reports have been filed for this event.Please see associated report: 3007963827-2022-00304.Customer has indicated that the product will not be returned to zimmer biomet for evaluation.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.The following sections have been updated: b1; b4; b5; g3; h2; h6; h10.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Approximately two years post-implantation, the patient underwent revision surgery of the tibial component due to tibial subsidence.The tibial component and articular surface were exchanged without complication.It was reported that no further information is available.
Additional Manufacturer Narrative
Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The condition of the components is unknown.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided but could not be assessed as they are incomplete.Complete records are not available.X-ray review by a third party states radiolucency along the cement order interface of the lateral aspect of the tibial component could indicate early loosening.Root cause was unable to be determined.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: NATURAL TIBIA TM TWO-PEG POROUS FIXED BEARING LEFT SIZE C
• 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: 15914800
• Report Number: 0001822565-2022-03352
• Device Sequence Number: 14539920
• Product Code: MBH
• UDI-Device Identifier: 00889024246478
• UDI-Public: (01)00889024246478(17)271031(10)77007002
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2023

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 Model Number: 42-5300-064-01
• Device Catalogue Number: 42530006401
• Device Lot Number: 77007002
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 03/10/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/30/2022; 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 57 KG