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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISC CONDYLE KIT W ALIGNMENT PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. DISC CONDYLE KIT W ALIGNMENT PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Concomitant: unknown, unknown srs humeral component, unknown. Customer has indicated that the product will not be returned 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: 0001825034 - 2018 - 01190.
 
Event Description
It was reported that during an elbow surgery the screws did not thread easily into the humeral body assembly after the elbow implant was reduced. The surgeon indicated that he tried two more screws for final assembly and had the same issue but was able to screw down the screws to complete the surgery. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to not be reportable. Zimmer biomet does not have reporting responsibility for the condyle kit so that report was submitted in error. Zimmer biomet has reported the event on 0001825034-2018-01190.
 
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Brand NameDISC CONDYLE KIT W ALIGNMENT
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 Key7286039
MDR Text Key100791428
Report Number0001825034-2018-01189
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK013042
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 03/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number114990
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 Received03/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

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