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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HUMERAL SCREW KIT 2 HUMERAL SCREWS SCREW, FIXATION

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ZIMMER BIOMET, INC. HUMERAL SCREW KIT 2 HUMERAL SCREWS SCREW, FIXATION Back to Search Results
Model Number 00-8400-090-00
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 02/15/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign country: (b)(4). Concomitant medical products: humeral component plasma sprayed size 4 150 mm length: cat: 00840004415, lot: 62908109. Ulnar component plasma sprayed size 5 75 mm length: cat: 00840002507, lot: 63399782. 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 report will be submitted.
 
Event Description
It was reported that the patient was noted to have ulnar and humeral component loosening in a radio graph review. A revision procedure has not been indicated at this time.
 
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Brand NameHUMERAL SCREW KIT 2 HUMERAL SCREWS
Type of DeviceSCREW, FIXATION
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 Key12693484
MDR Text Key278380406
Report Number0001822565-2021-03105
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K123862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number00-8400-090-00
Device Catalogue Number00840009000
Device Lot Number64160098
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 Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/25/2021 Patient Sequence Number: 1
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