• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. COONRAD/MORREY PIN/B USHING REPLACEMENT KIT ELBOW PROSTHESIS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER, INC. COONRAD/MORREY PIN/B USHING REPLACEMENT KIT ELBOW PROSTHESIS Back to Search Results
Catalog Number 32810502501
Device Problems Fracture (1260); Naturally Worn (2988); Insufficient Information (3190)
Patient Problems Osteolysis (2377); No Information (3190)
Event Date 11/11/2016
Event Type  Injury  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It is reported the patient has a planned revision surgery to revise the bearing.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Current information is insufficient to permit a conclusion as to the cause of the event.
 
Event Description
It is now known that the patient underwent elbow arthroplasty revision due to osteolysis around the humeral component and wear and breakage of the polyethylene bushings.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch. Subcomponent items were received for evaluation and the dimensions able to be taken were within specification. It was found that the ulna and humeral bushing show severe damage. Inner pin contains debris and outer pin shows wear. The device history records cannot be reviewed since the lot number is unknown. This device is used for treatment. Surgical technique and notes were not provided. It was noted that osteolysis was found around the humeral component however a definitive root cause of the reported issue cannot be determined with the information provided.
 
Event Description
It was reported that patient underwent an elbow arthroplasty revision approximately fourteen years post-implantation due to bushing wear and fracture, and osteolysis around the humeral component. The bushings were removed and replaced.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOONRAD/MORREY PIN/B USHING REPLACEMENT KIT
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
kathleen smith
p.o. box 708
warsaw, IN 46580
8006136131
MDR Report Key6096608
MDR Text Key59715745
Report Number0001822565-2016-04180
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number32810502501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2017
Was Device Evaluated by Manufacturer? Yes
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: 11/11/2016 Patient Sequence Number: 1
-
-