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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN COONRAD/MORREY ELBOW IMPLANT ELBOW PROSTHESIS

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ZIMMER, INC. UNKNOWN COONRAD/MORREY ELBOW IMPLANT ELBOW PROSTHESIS Back to Search Results
Device Problem Difficult to Remove (1528)
Patient Problem No Code Available (3191)
Event Date 12/29/2016
Event Type  Injury  
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Sections could not be completed with the limited information provided. This report is number 2 of 2 mdrs filed for the same patient (reference 1822565-2017-00360).
 
Event Description
It is reported that during an attempted elbow arthroplasty revision, the surgeon was unable to remove the hinge pin to remove the implants. The surgeon closed the surgical site and scheduled the revision a month later to remove the devices.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
 
Event Description
It was reported that during an attempted elbow arthroplasty revision, the surgeon was unable to remove the hinge pin to remove the implants. The surgeon closed the surgical site and scheduled the revision a month later to remove the devices. Additional information received stated that the surgeon initially attempted the removal of the devices with incorrect instrumentation, as it was unknown that the devices were zimmer biomet components. The surgeon did not realize he had the wrong tools until the surgery was performed. The devices were successfully removed one month later.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. The complaint sample could not be evaluated physically or through review of device history records as the part number / lot number of the device involved in the incident is unknown and the reported event was unable to be confirmed due to the limited information received from the customer. However, it was mentioned from the field that, "[the surgeon] thought [the implant] was a different company's prosthesis that was implanted, so he did not have the necessary removal tool for the case. We successfully removed it and reimplanted a new prosthesis on [a later date]. " a review of the complaint history could not be performed as the part / lot number of the device involved is unknown. It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique. As the necessary tools for removal were not used initially, there is determined to be no alleged deficiency against the implanted device reported.
 
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Brand NameUNKNOWN COONRAD/MORREY ELBOW IMPLANT
Type of DeviceELBOW 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 Key6281325
MDR Text Key65896425
Report Number0001822565-2017-00362
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2017
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 Treatment Data
Date Received: 01/26/2017 Patient Sequence Number: 1
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