MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD XP RIGHT MEDIAL BEARING 9MM X 79/83MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Erythema (1840); Swelling (2091); Thrombosis (2100)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi #: (b)(4).Concomitant medical products ¿ vanguard xp right lateral bearing 9mm x 79/83mm catalog #: 195786 lot #: 776680, vanguard series-a thin patella 34mm catalog #: 184786 lot #: 415080, vanguard xp femoral component right with pegs 72.5mm catalog #: 195913 lot #: 378570, vanguard xp interlok primary tibial tray 79mm catalog #: 195758 lot #: ni.Report source: report source.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event.0001825034-2019-04322, 0001825034-2019-04323, 0001825034-2019-04324, 0001825034-2019-04325, 0001825034-2019-04326.Investigation incomplete.

Event Description

It is reported that the patient had developed leg swelling, deep vein thrombosis and minor erythema eight (8) days following knee arthroplasty.The patient was treated with elevation and twenty-four (24) hours of antibiotics.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

Upon receipt of medical records, it was identified that the zimmer biomet devices used did not cause or contribute to the reported adverse reaction.Zimmer biomet does not consider this event to be a complaint at this time.

• Brand Name: VANGUARD XP RIGHT MEDIAL BEARING 9MM X 79/83MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9129586
• MDR Text Key: 160493689
• Report Number: 0001825034-2019-04322
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K132873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2019
• Device Model Number: N/A
• Device Catalogue Number: 195856
• Device Lot Number: 803960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 84