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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12352820
• Report Number: 0001825034-2021-02476
• Device Sequence Number: 16955345
• Product Code: HRY
• UDI-Device Identifier: 00880304180642
• UDI-Public: (01)00880304180642(17)240807(10)924230
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K042093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2024
• Device Model Number: N/A
• Device Catalogue Number: US154703
• Device Lot Number: 924230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention