MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD AS TIB BRG 16X71; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vanguard cr por fmrl-lt 62.5, p/n 183066, l/n: 928230; biomet finn locking bar; p/n: unknown, l/n: unknown.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report(s): 0001825034 - 2018 - 09161; 0001825034 - 2018 - 09163; 0001825034 - 2018 - 09165.

Event Description

It was reported the patient underwent an initial left knee arthroplasty 2 years post implantation.Subsequently, the patient was revised due to pain, implant fractures and loosening.No additional patient consequences were reported.

• Brand Name: E1 VNGD AS TIB BRG 16X71
• 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: 7943802
• MDR Text Key: 123046088
• Report Number: 0001825034-2018-09154
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-189066
• Device Lot Number: 738220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 118