MAUDE Adverse Event Report: ZIMMER BIOMET, INC. E1 VNGD PS+ TIB BRG 71/75X10; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Metal Related Pathology (4530)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: catalog # 141356, regenerex 3 peg series a patella dcm arcom porous titanium lot # 561780.Catalog #: 184512, vngd ps open por fmrl rt 70, lot # 421160.Catalog #: 141316, biomet finned pri stem 80x10mm, lot # 980570.Catalog #: 141274, bmet regenx pri tib tray 75mm, lot # 504580.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2019-01920.

Event Description

It was reported that the patient underwent an initial right knee procedure approximately two years ago.Subsequently, the patient suffered pain in the knee joints and has a fractured patella.Further it was reported that the patient was revised due pain, implant fracture, metallosis, necrotic tissue and bone.

• Brand Name: E1 VNGD PS+ TIB BRG 71/75X10
• 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: 10970258
• MDR Text Key: 246835557
• Report Number: 0001825034-2020-04294
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: N/A
• Device Catalogue Number: EP-183740
• Device Lot Number: 403580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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