• 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. UNKNOWN COONRAD-MORREY IMPLANT 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. UNKNOWN COONRAD-MORREY IMPLANT ELBOW PROSTHESIS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Ossification (1428); Loss of Range of Motion (2032); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Roskidaylo et al. "total elbow replacement coonrad-morrey in patients with rheumatoid arthritis. " orthopaedic, fsbi research institute of rheumatology. 72:a892. 3-a892. 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 a roskidaylo, a logunov, s makarov and v amirdjanova.
 
Event Description
It is reported in a journal article that two patients experienced elbow stiffness following elbow arthroplasty. No further information is available.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. This information does not change the root cause of the investigation previously provided.
 
Manufacturer Narrative
This follow-up is being submitted to relay additional information. Date implanted - x-rays taken post-operatively indicate that the patient was implanted on or prior to (b)(6) 2012.
 
Event Description
It is reported in a journal article that one patient experienced elbow stiffness following elbow arthroplasty. No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Provided radiographs were evaluated, and the reported event was not confirmed. X-ray reviewer stated, "elbow x-rays all show presence of coonrad/morrey semiconstrained total elbow arthroplasty components and posterior skin staples. On one set of lateral elbow x-rays (date unknown), bone graft is visualized between the anterior flange of the humeral component and the humeral cortex. The flange and bone graft are meant to resist torsional and posteriorly directed forces. No radiographic finding is present indicating an obvious cause for "elbow stiffness. " neither device history record (dhr) review or complaint history review was able to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN COONRAD-MORREY 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 Key6333201
MDR Text Key67534158
Report Number0001822565-2017-00730
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2017
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: 02/15/2017 Patient Sequence Number: 1
-
-