MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS TIB BRG 10X63/67MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Scar Tissue (2060)

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: china.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: 183122 van ps open intl fem-lt 57.5 lot# j6791852 mdr: 0001825034-2023-01141.141232 biomet cc cruciate tray 67mm lot# j6908834 mdr: 0001825034-2023-01142.11-150840 bmet arcom ap pat 3pst 31mm sm lot# unk mdr: 0001825034-2023-01195.Additional associated products: unk bone cement.

Event Description

It was reported an initial left total knee arthroplasty was performed.Subsequently one year, two months post procedure the patient began 1st stage revision due to infection and loosening.During the revision noted inflammatory scar tissue to joint cavity and a pus cavity to lateral platform of femoral condyle.The femur and tibia components exchanged with antibiotic cement spacers, unknown if patella was removed.Treated with antibiotics.The 2nd stage revision was completed with competitor products.No further information provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, h10  it was reported that approximately 1 year post initial total knee arthroplasty, the patient was revised due to inflammatory scar tissue and loosening, both attributed to an infectious process.During the investigation process a review of the sterile certifications for the femoral, tibial, and bearing components were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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.

Event Description

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

• Brand Name: VNGD PS TIB BRG 10X63/67MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16991861
• MDR Text Key: 315849442
• Report Number: 0001825034-2023-01143
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00880304271852
• UDI-Public: (01)00880304271852(17)250807(10)409900
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113550
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 183620
• Device Lot Number: 409900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female