MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CRUCIATE RETAINING TIBIAL BEARING 10MM X 71MM/75MM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Urinary Tract Infection (2120)

Event Date 09/01/2006

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products ¿ vanguard cruciate retaining interlok femoral component right 65mm, catalog #: 183008, lot #: ni, biomet cc i-beam tibial tray 71mm, catalog #: 141223, lot #: ni, unknown biomet arcom 3 peg patella 28mm ,catalog #: ni, lot #: ni.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The complaint sample was not evaluated and the reported event could not be confirmed.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 1825034-2018-10269; 1825034-2018-10271; 1825034-2018-10272.

Event Description

It is reported that the patient was treated with cipro and pyridium to address a urinary tract infection that developed within eight (8) days following right knee arthroplasty.No additional patient consequences were reported.

• Brand Name: VANGUARD CRUCIATE RETAINING TIBIAL BEARING 10MM X 71MM/75MM
• 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: 8044185
• MDR Text Key: 126346880
• Report Number: 0001825034-2018-10270
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• 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: 183440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2018
• 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): Required Intervention
• Patient Weight: 92