MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL AUGMENT BLOCK PRECOAT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erosion (1750); Failure of Implant (1924); Inflammation (1932); Necrosis (1971); Scar Tissue (2060)

Event Date 02/02/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2- australia.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-01725, 0002648920-2023-00137, 0001822565-2023-01726, 0001822565-2023-01727, 0001822565-2023-01728, 0001822565-2023-01729, 0001822565-2023-01731.D10-medical product: size 4 precoat cemented tibial component item# 00588000400 lot# 65245252.15mm 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.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 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.

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.A definitive root cause cannot be determined for loosening of the femur and associated femoral components.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.

Event Description

No further event information available at the time of this report.

• Brand Name: DISTAL FEMORAL AUGMENT BLOCK PRECOAT
• Type of Device: 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: 17228938
• MDR Text Key: 318177833
• Report Number: 0001822565-2023-01730
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024224193
• UDI-Public: (01)00889024224193(17)260831(10)63430889
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00599003620
• Device Lot Number: 63430889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female