MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 18X24 MM IMPLANT HEAD; PROSTHESIS, EXTREMITIES

Catalog Number 11-210045

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00740.Concomitant medical products: part# 11-210061 lot# 479750.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

Event Description

It was reported that patient underwent a left elbow procedure approximately twelve (12) years ago.Subsequently, patient was revised approximately six (6) months ago and converted to a total elbow due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: EXPLOR 18X24 MM IMPLANT HEAD
• Type of Device: PROSTHESIS, EXTREMITIES
• 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: 10244858
• MDR Text Key: 197968972
• Report Number: 0001825034-2020-02669
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Catalogue Number: 11-210045
• Device Lot Number: 949220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention