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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. COONRAD/MORREY EXTRA SMALL INTERCHANGEABLE ULNAR ASSEMBLY PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Tissue Damage (2104); Fracture, Arm (2351)
Event Type  Injury  
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. Patient anatomy caused the reported event. 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). The product will not be returned to zimmer biomet for investigation, as the product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: coonrad/morrey extra small interchangeable humeral assembly. Catalog#: 32810502704, lot#: 62628990.
 
Event Description
It is reported that the patient is scheduled to undergo a right elbow arthroplasty revision to accurately span the patient's humerus to her radius within her specific anatomical parameters. Additionally, it is noted that due to the patient's ulnar hypoplasia, the ulnar bone was unavailable for fixation during initial implantation and the surgeon placed the ulnar component proximally from the ulna distally into the radius. Subsequently, the patient began experiencing issues approximately eighteen months post-operatively and has experienced loosening of the ulnar component in the radius, fracture of the radius and bone loss.
 
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Brand NameCOONRAD/MORREY EXTRA SMALL INTERCHANGEABLE ULNAR ASSEMBLY
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7042752
MDR Text Key257089583
Report Number0001822565-2017-07962
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
PK053189
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 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model NumberN/A
Device Catalogue Number32810504302
Device Lot Number62608392
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 Received01/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2014
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: 11/17/2017 Patient Sequence Number: 1
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