MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SIZE 4 PRECOAT CEMENTED TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Failure of Implant (1924); Inflammation (1932); Necrosis (1971); Scar Tissue (2060)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2- australia.Multiple mdr reports were filed for this event, please see associated report: 0002648920-2023-00137, 0001822565-2023-01726, 0001822565-2023-01727, 0001822565-2023-01728, 0001822565-2023-01729, 0001822565-2023-01730, 0001822565-2023-01731.D10-medical product: 15mm diameter 30mm length straight stem extension item# 00598801215 lot# 64894141; articular surface with segmental hinge post size f 12 mm height item# 00585006012 lot# 65154720; right size f cemented option femoral component item# 00588001602 lot# 64572044; distal femoral augment block precoat item# 00599003610 lot# 64093693; long 13mm diameter 155mm length offset stem extension item# 00598802113 lot# 64029639; distal femoral augment block item# 00599003620 lot# 63430889; prc agmt block post sz f 5mm item# 00599003601 lot# 64100145; unknown palacos bone cement.G2- australia h3- 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
It was reported that a patient was revised approximately eight and half month's post implantation due to loosening with bone erosion and necrosis.A patient underwent right total knee arthroplasty with unknown implants on an unknown date and was subsequently revised with a stage i unknown cement spacer on an unknown date due to mssa infection.A stage ii implantation with a rotating hinge construct was performed during which, there was no evidence of persistent infection.All existing hardware and spacers were removed.An rhk was placed without complications.The patient did well until presenting with possible reinfection and evidence of femorotibial implant malrotation, patellar erosion, and bone necrosis.The patient was taken to the operating room approximately eight and a half months later; however, the surgeon decided to abort the procedure and have the patient return when culture results were available.Three days later, the patient returned to surgery for a full revision.During the revision the femoral component was clearly loose at the cement-bone interface.Extensive bone loss and defects were noted in the femoral, tibial, and patellar regions.A tibial tubercle osteotomy was performed to remove the tibial components and was secure with wires.Upon revision of tibial and femoral components with implantation of a patellar component, good tracking and stability was achieved.Attempts to obtain additional information have been made; however, no more information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: necrotic debris and fibrosis on arthrotomy with histology samples taken, no results provided, femoral loosening, tibial and patella bone loss, tibial tubercle osteotomy (tto) fashioned / secured with 4 charnley wires.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.For the reported infection, the issue was determined to be unrelated to the implanted zimmer biomet devices.The complaint is confirmed via medical records.If any further information is received 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: SIZE 4 PRECOAT CEMENTED 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: 17229503
• Report Number: 0001822565-2023-01725
• Device Sequence Number: 7076268
• Product Code: JWH
• UDI-Device Identifier: 00889024199026
• UDI-Public: (01)00889024199026(17)261209(10)65245252
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 10/24/2023

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: N/A
• Device Catalogue Number: 00588000400
• Device Lot Number: 65245252
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female