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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN COONRAD-MORREY ULNAR COMPONENT ELBOW PROSTHESIS

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ZIMMER, INC. UNKNOWN COONRAD-MORREY ULNAR COMPONENT 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
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 ulnar component loosening following elbow arthroplasty. No further information is available.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Implant date - a post-operative x-ray indicates that the patient was implanted on or prior to (b)(6) 2014.
 
Event Description
It is reported in a journal article that one patient experienced left ulnar component loosening two years following elbow arthroplasty. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
The complaint sample was evaluated through radiographic inspection and the reported event could not be confirmed. A review of the x-ray provided revealed that, "there is no gross evidence of loosening of humeral or ulnar components on this lateral x-ray. Gas in the soft tissues suggests this x-ray may have been acquired in the early postoperative period. " a device history record review was unable to be performed as the lot number of the device involved in the event is unknown. A review of the complaint history was unable to be performed as no part or lot number was provided. The root cause remains unable to be determined. 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.
 
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Brand NameUNKNOWN COONRAD-MORREY ULNAR COMPONENT
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 Key6333202
MDR Text Key67534066
Report Number0001822565-2017-00728
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
Report Date 05/12/2017
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? Yes
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 Received05/12/2017
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
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