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

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.

• Brand Name: UNKNOWN COONRAD/MORREY ELBOW IMPLANT
• 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: 6281325
• MDR Text Key: 65896425
• Report Number: 0001822565-2017-00362
• 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: Physician
• 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 Received: 01/26/2017
• 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?: Yes
• Date Manufacturer Received: 03/13/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Other