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U.S. Department of Health and Human Services

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

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ZIMMER, INC. UNKNOWN COONRAD-MORREY ULNAR COMPONENT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
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. Date implanted - post-operative x-rays indicate that the devices were implanted on or prior to (b)(6) 2012. Initial reporter - the article was written by a roskidaylo, a logunov, s makarov and v amirdjanova. Device evaluated by manufacturer - the device has been requested for return, but no response was received from the journal article author that indicates that product will be returned.
 
Event Description
It is reported in a journal article that one patient underwent left elbow arthroplasty revision due to loosening of the ulnar component two years following elbow arthroplasty secondary to incorrect implantation. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
The complaint sample was reviewed through an x-ray review and the reported event was confirmed. An x-ray review confirmed that, "earlier x-rays show loosening of the ulnar component with ulnar stem malpositioned in varus alignment, and with the distal stem breaching the posterior lateral cortex of the ulna surrounded by chronic periosteal new bone surrounding the distal stem. A later x-ray shows distal migration/loosening of the humeral component. Later x-rays also show revision of the ulnar component, with the new ulnar stem breaching the lateral cortex of the ulna distally and apparent loosening of the ulnar component. " it was further noted, "bones appear osteopenic, possibly contributing to migration/loosening of the ulnar component". 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 the part and lot number is unknown. Investigation results concluded that the reported event was due to incorrect implantation of the ulnar component, as previously reported by the author of the journal article.
 
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Brand NameUNKNOWN COONRAD-MORREY ULNAR COMPONENT
Type of DevicePROSTHESIS, ELBOW
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 Key6417935
MDR Text Key70362536
Report Number0001822565-2017-01733
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeRS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
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: 03/20/2017 Patient Sequence Number: 1
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