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

Device Problems Detachment Of Device Component (1104); Fracture (1260); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Sietz et al."failure of the hinge mechanism in total elbow arthroplasty." j shoulder elbow surg (2010).19:368-375.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.Initial reporter - the article was written by william h.Seitz jr., hisham bismar and peter j.Evans involving hospitals cleveland clinic hospital, kaiser permanente hospital and the cleveland clinic, ohio, united states of america.

Event Description

It is reported in a journal article that one patient underwent elbow arthroplasty revision due to a third instance of locking mechanism failure.The patient was revised to a more durable, custom-made locking mechanism.No further information is available.

Manufacturer Narrative

This follow-up report is being filed to correct information.This information does not change the investigation previously reported.

Event Description

It is reported in a journal article that one patient underwent elbow arthroplasty revision due to a third instance of locking mechanism failure.The patient was revised to a more durable, custom-made locking mechanism.No further information is available.Additionally, the article mentions that the failed locking mechanisms were due to either pin fracture or dissociation of the pin components.However, it is unclear for these patients, what specific failures occurred.

• Brand Name: UNKNOWN COONRAD-MORREY HUMERAL COMPONENT
• Type of Device: ELBOW PROSTHESIS
• 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: 6331346
• MDR Text Key: 67442227
• Report Number: 0001822565-2017-00760
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

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?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention