MAUDE Adverse Event Report: ZIMMER BIOMET, INC. C/M HUMERAL ASSY 6 IN SML; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 09/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event.Please also see associated report(s): 0001822565 - 2018 - 00974.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was report the patient was revised to address implant fracture.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional: updated reported event was confirmed by review of x-rays provided.Per the review, fractured left elbow arthroplasty.Lucencies along the humeral and ulnar components consistent with loosening.Dhr 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.

Manufacturer Narrative

(b)(4) the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: C/M HUMERAL ASSY 6 IN SML
• 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: 7278593
• MDR Text Key: 100398422
• Report Number: 0001822565-2018-00973
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: PK001989
• 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,Followup,Followup
• Report Date: 05/23/2018

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 Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 32-8105-025-06
• Device Lot Number: 62774244
• Other Device ID Number: (01) 00889024273948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 02/15/2018; 05/21/2018
• Supplement Dates FDA Received: 03/14/2018; 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2014
• 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: 65 YR
• Patient Weight: 75