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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM PROSTHESIS, ELBOW

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ZIMMER BIOMET, INC. HUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM PROSTHESIS, ELBOW Back to Search Results
Catalog Number 00840004510
Device Problems Difficult to Insert (1316); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Udi#: (b)(4). Concomitant medical devices: 00840009000 humeral screw kit 2 humeral screws 64608099; 00-8400-095-00 articulation kit size 5/6 64479729; 00-8400-025-07 ulnar-stem-sz5-75mm-rt 64450052. Foreign- (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. 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 - 2020 - 02884.
 
Event Description
It was reported that one out of two locking screws could not be fixated during implantation. It was jammed about halfway in and it was impossible to screw it tighter or unscrew it. Another drill was opened but it could not be fixed. To further avoid damaging the screw, it was kept as it was and the surgery was completed. There was about 35 minutes of surgical delay.
 
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Brand NameHUMERAL COMPONENT PLASMA SPRAYED SIZE 5 100 MM
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 Key10391650
MDR Text Key202403723
Report Number0001822565-2020-02883
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K123862
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 11/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00840004510
Device Lot Number64571213
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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