MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD PATELLAR SYSTEM 31MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Fall (1848); Tissue Damage (2104)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown femoral component, unknown tibial component, unknown tibial bearing.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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

It was reported that the patient underwent knee arthroplasty and subsequently, fifteen years later the patient had to undergo a patella revision was done due to patella fracture and a ruptured quad tendon that occurred when the patient fell.

Manufacturer Narrative

(b)(4).This complaint was not confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.An x-ray was provided; however, it was not reviewed as the complaint is for a poly patella which is not visible on an x-ray.Further medical records were not provided.A definitive root cause cannot be determined.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: VANGUARD PATELLAR SYSTEM 31MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8611905
• MDR Text Key: 145111027
• Report Number: 0001825034-2019-02156
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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 Expiration Date: 06/30/2009
• Device Model Number: N/A
• Device Catalogue Number: 11-150826
• Device Lot Number: 398890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/17/2019
• 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: 80 YR