MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PARTIAL FEMUR CEMENTED; KNEE PROSTHESIS

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a 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 sales rep noticed inside packaging of implant was cut open; the sterility of the product is compromised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The femoral component and it's packaging were returned.Form the returned product evaluation it was determined that the box was opened on the wrong side with a clean cut and both the inner and outer tyvek has been cut open.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.

• Brand Name: PERSONA PARTIAL FEMUR CEMENTED
• Type of Device: KNEE PROSTHESIS
• 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: 7278809
• MDR Text Key: 100515982
• Report Number: 0001825034-2018-01057
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000601
• Device Lot Number: 63571319
• Other Device ID Number: (01) 00880304808492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 04/13/2018; 04/13/2018
• Supplement Dates FDA Received: 04/13/2018; 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2017
• 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