MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN VANGUARD FEMORAL COMPONENT; PROSTHESIS, KNEE

Catalog Number UNK VANGUARD FEMORAL COMPONENT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Synovitis (2094)

Event Date 06/29/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial total left knee arthroplasty.For 15 months post implantation, the patient has been experiencing pain, synovitis, and reduced mobility.The patient has been seeking treatment to assess and determine whether an allergic reaction is occurring.At the time of this report, products remain implanted.Final outcome is pending.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Multiple mdr reports have been filed for this event.Please see associated reports: 0001825034-2021-03288; 0001825034-2021-03290; 0001825034-2021-03291.Concomitant medical products: unknown vanguard tibial tray: catalog#ni, lot#ni; unknown vanguard articular surface: catalog# ni, lot# ni; unknown vanguard patella component: catalog # ni, lot # ni.Report source: foreign: (b)(6).Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial total left knee arthroplasty.For 15 months post implantation, the patient has been experiencing pain, synovitis, and reduced mobility.Knee aspirated on unknown date with results of staphylococcus warnerai, indicating infection of knee.Symptoms started approximately 5 weeks post implantation.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Insufficient information provided to perform a compatibility check.Complaint history review cannot be performed without product identification.Medical records were provided and reviewed by a health care professional.Review found patient tested positive for staphylococcus warneri, indicating infection of knee.Allergy test results found patient demonstrates contact dermatitis (sensitivity/allergy) to nickel, cobalt, palladium, zinc, and other listed allergens.Further medical records were not provided.The patient tested positive for staphylococcus warnerai however as product information was not provided it cannot be confirmed whether the patient is allergic to their implants.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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: UNKNOWN VANGUARD FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12951508
• MDR Text Key: 281843715
• Report Number: 0001825034-2021-03289
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK VANGUARD FEMORAL COMPONENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/09/2021; 02/25/2022
• Supplement Dates FDA Received: 12/31/2021; 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female