MAUDE Adverse Event Report: ZIMMER, INC. - BUILDING 5 COONRAD/MORREY HUMERAL ASSEMBLY; JDC

Catalog Number 32810502704

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient's elbow arthroplasty was revised due to the humeral condyles fracturing after a fall.

Manufacturer Narrative

No device or photos were received; therefore the condition of the component is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Product history search cannot be completed since the lot number is unknown.Compatibly cannot be verified since the part and lot information of the ulnar component is unknown.It is likely that the alleged patient fall contributed to the fracture of the humeral condyles.

• Brand Name: COONRAD/MORREY HUMERAL ASSEMBLY
• Type of Device: JDC
• Manufacturer (Section D): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC. - BUILDING 5; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5594469
• MDR Text Key: 43216865
• Report Number: 0001822565-2016-01242
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 32810502704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• 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): Hospitalization; Required Intervention