MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OSSEOTI TRANSDERMAL ADAPTER; PROSTHESIS, KNEE

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Skin Irritation (2076); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon noticed skin irritation that is occurring as a result of the soft tissue flange portion of the implant impinging with the newly formed redundant skin tissue.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: badia tdermal stm 19mm x 120mm, catalog#: cp116597, lot#: 907180.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.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.

• Brand Name: OSSEOTI TRANSDERMAL ADAPTER
• 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: 7116577
• MDR Text Key: 94803614
• Report Number: 0001825034-2017-11124
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: CP116598
• Device Lot Number: 234430
• Other Device ID Number: (01) 0 0880304 85797 1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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
• Patient Outcome(s): Required Intervention