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

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Erosion (1750); Failure of Implant (1924); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised following an elbow arthroplasty due to unknown reasons.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.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.Surgical notes were not provided; 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.

Manufacturer Narrative

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

Event Description

It is reported that the patient is being considered for right elbow arthroplasty revision due to loosening of the ulnar component and bone loss and/or erosion.No further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Foreign - (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event update has been received at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No additional information has been obtained pertaining to this event, therefore, the root cause remains as is.

Event Description

No event update is available at the time of this report.

• Brand Name: COONRAD/MORREY ELBOW ULNA
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• MDR Report Key: 6090179
• MDR Text Key: 59512000
• Report Number: 0001822565-2016-04141
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 10/06/2020; 03/09/2021
• Supplement Dates FDA Received: 01/25/2017; 03/03/2017; 10/20/2020; 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention