MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXPLOR 8X28MM IMPL STEM W/SCR; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Date 07/27/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-210033, explor 14x22mm implant head, 792030.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 reports: 0001825034 - 2018 - 00784.Product location unknown.

Event Description

It was reported that the patient underwent left elbow arthroplasty.Subsequently, the patient was revised due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

It was determined this reporting is a duplicate of (b)(4).This device was found to be not reportable to this event.Please void this submission.

• Brand Name: EXPLOR 8X28MM IMPL STEM W/SCR
• Type of Device: PROSTHESIS, ELBOW
• 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: 7279681
• MDR Text Key: 100408375
• Report Number: 0001825034-2018-00785
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-210063
• Device Lot Number: 839040
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2009
• 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: 41 YR
• Patient Weight: 95