MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VANGAURD PS TIBIAL BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: biomet cc i-beam tray cat#: 141226, lot#: j3563825; vangaurd ps open femoral cat#: 183132, lot#: j3687996; biomet patella arcom cat#: 11-150842, lot#: 316730; e1 vngd ps tib brg 79/83x10 cat#: ep-183660, lot#: 81984446.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01309, 0001825034 - 2018 - 01310, 0001825034 - 2018 - 01311, 0001825034 - 2018 - 01312.Remains implanted.

Event Description

It was reported that the patient is experiencing pain and bumps on inside the knee ten months after a left knee arthroplasty.

Manufacturer Narrative

Udi (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.No devices were received; therefore the condition of the component is unknown.Dhr was reviewed for deviations and / or anomalies with no related deviations / anomalies identified.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.

Event Description

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

• Brand Name: E1 VANGAURD PS TIBIAL BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7290566
• MDR Text Key: 100765725
• Report Number: 0001825034-2018-01309
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PK113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

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
• Device Operator: Physician
• Device Expiration Date: 12/10/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-183660
• Device Lot Number: 371970
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention