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U.S. Department of Health and Human Services

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

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ZIMMER, INC. COONRAD/MORREY SMALL ULNAR ASSEMBLY PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 04/14/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Radiographic evaluation of the lateral view of the right elbow does not confirm or exclude the reported event. Evaluation for polyethylene wear of bushings and hinge failure cannot be made due to lack of ap x-ray view. 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. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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
Current information is insufficient to permit a conclusion as to the cause of the event. Concomitant devices - coonrad/morrey small humeral assembly catalog #: 32810500400 lot #: 34469800, howmedica simplex cement catalog #: 6191-1-001 lot #: rkc 090. The customer has indicated that the device will not be returned to zimmer biomet for evaluation, as the device was discarded. The investigation is in process. Once the investigation is completed, a follow-up mdr will be submitted. This report is number 1 of 2 mdrs filed for the same patient (reference 0001822565-2017-03150).
 
Event Description
It is reported that the patient underwent an elbow arthroplasty revision due to wear twenty-one (21) years following implantation. Only the bushings and hinge pin were exchanged utilizing ulnar and humeral replacement kits while leaving the implants themselves in the patient. No further patient consequences were reported.
 
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Brand NameCOONRAD/MORREY SMALL 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 Key6556720
MDR Text Key109402439
Report Number0001822565-2017-03149
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK883665
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32810500200
Device Lot Number34470400
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 Received07/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/1995
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: 05/10/2017 Patient Sequence Number: 1
Treatment
SEE H10 NARRATIVE; SEE H10 NARRATIVE
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