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U.S. Department of Health and Human Services

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

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ZIMMER, INC. COONRAD/MORREY INTERCHANGEABLE ULNAR ASSEMBLY PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Fracture, Arm (2351)
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint was confirmed through review of radiographs. There are warnings in the package insert that this type of event can occur and associate risks are addressed in risk documentation. Device history report was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Root cause of the event could not e 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.
 
Manufacturer Narrative
(b)(6). Implant date was in 2010. Customer has indicated that the product might be returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It is reported that the patient underwent right total elbow surgery on an unknown date. Approximately 7 years later, the patient is indicated for revision due to ulnar component fracture and bone fracture during day-to-day tasks. A custom implant has been requested to perform the revision. No revision has been reported to date, and no other serious injury is reported. No further information has been provided.
 
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Brand NameCOONRAD/MORREY INTERCHANGEABLE ULNAR ASSEMBLY
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 Key6477066
MDR Text Key111559817
Report Number0001822565-2017-02134
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
PK001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberN/A
Device Catalogue Number32810509302
Device Lot Number62859963
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/10/2017 Patient Sequence Number: 1
Treatment
UNKNOWN CEMENT CAT#: NI LOT#: NI
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