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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY ELBOW PROSTHESIS

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ZIMMER, INC. COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY ELBOW PROSTHESIS Back to Search Results
Catalog Number 32810502704
Device Problems Break (1069); Fracture (1260); Naturally Worn (2988)
Patient Problems Reaction (2414); No Code Available (3191)
Event Date 07/01/2015
Event Type  Injury  
Manufacturer Narrative
This report will be amended when our investigation is complete.
 
Event Description
It is reported the patient was revised due to an implant failure.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch as well as corrected information. 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. Surgical notes were not provided; 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. This report is number 2 of 2 mdrs filed for the same patient (reference 0001822565-2016-04029).
 
Event Description
Patient underwent an elbow arthoplasty revision procedure approximately five years post-implantation due to pin fracture, bushing wear, and metallosis with onset approximately four years post-operatively. The patient was placed in a cast for eight months prior to revision. The humeral and ulnar components remained implanted following revision.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Further investigation confirmed that the humeral pin is packaged with the coonrad/morrey total elbow interchangeable humeral assembly, sharing the same product identification. The previous medwatch 3500a report submitted under this mfr number reported an unknown humeral pin incorrectly. The complaint sample was evaluated through device history record review and an x-ray review and the reported event was confirmed. An x-ray report confirmed failure of locking pin and disassociation of locking pin. The report stated, "bone mineral density appears normal and there is no evidence of acute fracture or osteolysis. However, there are marked pre-existing bony deformities distal humerus, proximal ulna and proximal radius including absence of distal humeral metaphysis/condyles and absence of proximal ulna and radius. Pre-existing marked bony deformities, as well as young patient age, increase risk of bushing wear and locking pin failure. As far as can be visualized, the humeral stem is grossly midline within the humeral canal. The tip of the ulnar stem is only slightly off-center. Implant placement is unlikely a contributing factor to the reported event. " the device history records were reviewed and no discrepancies were found. A review of the complaint history determined that no further action is required, as no trends were identified. A definite root cause was unable to be determined.
 
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Brand NameCOONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY
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 Key6070602
MDR Text Key58918064
Report Number0001822565-2016-04030
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
PK001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2015
Device Catalogue Number32810502704
Device Lot Number61454861
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 Received03/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2010
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: 11/01/2016 Patient Sequence Number: 1
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