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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW SHOULDER, PROSTHESIS

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ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW SHOULDER, PROSTHESIS Back to Search Results
Model Number 47-2484-045-50
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 01/21/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: 5. 0 mm diameter cortical screw cat: 47248404050 lot: 64677063; 6. 0 mm diameter cancellous screw cat: 47248405060 lot: 64466394; greater trochanter femoral nail cat: 47249232011 lot: 62451700. Foreign: (b)(6). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up report will be submitted.
 
Event Description
It was reported that approximately 8 months post implantation, the patient experienced a fracture and the implanted nail had also fractured and become loose. The patient was revised. No further information has been provided.
 
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Brand Name5.0 MM DIAMETER CORTICAL SCREW
Type of DeviceSHOULDER, PROSTHESIS
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 Key11313428
MDR Text Key231352778
Report Number0001822565-2021-00370
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K082770
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 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number47-2484-045-50
Device Catalogue Number47248404550
Device Lot Number64581106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/11/2021 Patient Sequence Number: 1
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