MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BMET ARCOM AP PAT 3PST 31MM SM; 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: 0001825034-2023-01142.183620, vngd ps tib brg 10x63/67mm lot# 409900.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.For the patellar component, the sterile certifications were not reviewed, as no product lot information was provided.All devices manufactured follow acceptable sterilization processes according to published iso/aami/astm & eu 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.All products manufactured follow appropriate standards, and the reported infection occurred > 90 days; therefore, 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: BMET ARCOM AP PAT 3PST 31MM SM
• 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: 16991874
• MDR Text Key: 315849072
• Report Number: 0001825034-2023-01195
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• 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: 11-150840
• 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
• 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): Required Intervention; Hospitalization
• Patient Sex: Female