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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN COONRAD-MORREY IMPLANT; ELBOW PROSTHESIS Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Plaschke et al.Revision total elbow arthroplasty with the linked coonrad-morrey total elbow arthroplasty: a retrospective study of twenty procedures." international orthopaedics (sicot)(2013).37:853-858.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.Sections could not be completed with the limited information provided.Initial reporter - the article was written by hans christian plaschke, theis thillemann, anne kathrine belling-sorensen and bo olsen.
 
Event Description
It is reported in a journal article that one patient underwent elbow arthroplasty revision due to loosening nearly one and a half years following elbow arthroplasty.No further information is available.
 
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Brand Name
UNKNOWN COONRAD-MORREY 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 Key6328839
MDR Text Key67377609
Report Number0001822565-2017-00773
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 02/09/2017
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 Physician
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/16/2017
Initial Date FDA Received02/14/2017
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 Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age57 YR
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