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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 EXTRA SMALL PROSTHESIS, ELBOW

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ZIMMER, INC. COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Unstable (1667)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Fracture, Arm (2351); Osteolysis (2377)
Event Date 04/04/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of medical records. It is noted in imaging/test results portion of the medical records that "there is a transverse fracture of the humeral prosthesis. This occurred at the interface between the humeral canal and where the bone ends. There is some osteolysis around both the ulnar implant of the humeral implant. There is cement well up into the canal of the humerus. " device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action(s) is/are required. It is noted in medical records that the patient "has a demented husband who requires a lot of care. She has been lifting him at night with her only good arm which is her left arm. " it is stated in the instructions for use, "note: the prosthesis will not restore function to the level expected with a normal healthy joint, and has functional limitations. Excessive muscular activity, e. G. , pounding, carrying loads must be avoided or restricted. The patient must not lift more than one pound during the first three postoperative months and not more than five pounds with the operated arm. In addition, the risks and complications listed under adverse effects must be explained to and discussed with the patient. " root cause is determined to be related to the patient not following postoperative restrictions. 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)(4). Concomitant medical product - compact vacuum cement mixing system, cat#:00504903, lot#: 61949805. Customer has indicated that the product will not be returned [as location is unknown] to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03207.
 
Event Description
It was reported that the patient underwent a left elbow arthroplasty revision approximately 5 years post-implantation due to elbow pain/swelling with instability, clicking, and limited range of motion. Physician office notes and radiographs received note peri-prosthetic fracture and fracture of the humeral component, with osteolysis around the ulnar and humeral implant.
 
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Brand NameCOONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL
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 Key6560109
MDR Text Key106994524
Report Number0001822565-2017-03206
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK001989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2016
Device Model NumberN/A
Device Catalogue Number32810502704
Device Lot Number61883946
Other Device ID NumberN/A
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 Received07/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2011
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: 05/11/2017 Patient Sequence Number: 1
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