MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN COONRAD-MORREY TOTAL ELBOW; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.No device or photos were received; therefore the condition of the device is unknown.Device history records cannot be reviewed since the lot number is unknown.This device is used for treatment.Product history search cannot be completed since the lot number is unknown.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definite root cause cannot be determined with the information provided.The following could not be completed with the limited information provided.Date of death - ni, date of event - ni, device code - ni, expiration date - ni, date implanted - ni, date explanted - ni, initial reporter - the article was written by n.Prasad, a.Ali, and d.Stanley, manufacture date ¿ ni, this is 4 of 4 reports being filed for the same journal article (reference 1822565-2017-00822 / 00823 / 00824 / 00825).

Event Description

Information was received based on review of a journal article titled, "total elbow arthroplasty for non-rheumatoid patients with a fracture of the distal humerus: a minimum ten-year follow-up" which aimed to treat patients with distal humerus fracture using the coonrad-morrey elbow arthroplasty, manufactured by zimmer.Patients were identified in the article that underwent elbow arthroplasty on an unknown date.One patient was identified to have died less than 10 years after surgery and experienced symptomatic heterotopic ossification.There has been no further information provided.

• Brand Name: UNKNOWN COONRAD-MORREY TOTAL ELBOW
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6333139
• MDR Text Key: 67516186
• Report Number: 0001822565-2017-00825
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2017
• 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): Death