MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COONRAD-MORREY HUMERAL STEM; PROTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Pain (1994); Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event, unknown date, 2013.Concomitant medical products: unknown coonrad/morrey ulnar.Reported event was confirmed through receipt of doctor's office notes.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Doctor's office notes from (b)(6) 2013 state, (b)(6) female presents with complaint of pain in her left arm.During the first quarter of year 2013 the patient experienced a gastric bleed requiring a large amount of blood transfusions and icu hospitalization for a time period of one month.During this time the patient was apparently moved; lifted and transferred utilizing her left arm.When the patient regained consciousness she was experiencing extreme pain and notable deformity of her left arm.When patient stabilized, displaced fracture of distal humerus, implant failure was identified.Patient has remained immobilized with a removable long-arm splint; however, healing of the wound has delayed with patient still recovering from abdominal surgery.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.Report was initially submitted incorrectly under report number 0001825034-2017-06938.

Event Description

It is reported that patient presented to their doctor with elbow pain.The patient was treated with a cast.Review of doctor's office notes relay that the patient sustained a displaced distal humeral fracture with implant failure, following trauma.

• Brand Name: UNKNOWN COONRAD-MORREY HUMERAL STEM
• Type of Device: PROTHESIS, 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: 7172172
• MDR Text Key: 96634864
• Report Number: 0001822565-2018-00116
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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