MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD M UNI BRNG B5 RM/LL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review found patient presented with tibial plateau fracture and was then instructed to be non-weight bearing.The patient did not comply and was then admitted for a revision surgery.During the revision procedure there were small bone fragments when tibia and medial components were removed.No complications noted.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported a patient underwent an initial right partial knee arthroplasty performed.Subsequently, the patient underwent a revision approximately 2 weeks post-op due to tibial plateau fracture.The patient completed the study due to device removal.Converted to total knee arthroplasty without complications.

• Brand Name: VANGUARD M UNI BRNG B5 RM/LL
• 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: 12352820
• MDR Text Key: 267632766
• Report Number: 0001825034-2021-02476
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00880304180642
• UDI-Public: (01)00880304180642(17)240807(10)924230
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• 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: US154703
• Device Lot Number: 924230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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