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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLENOSPHERE ORIENTATION GUIDE EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES

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DEPUY ORTHOPAEDICS INC US GLENOSPHERE ORIENTATION GUIDE EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES Back to Search Results
Model Number 2307-95-000
Device Problem Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
It was reported that the instrument was reported as worn out.
 
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameGLENOSPHERE ORIENTATION GUIDE
Type of DeviceEXTREMITY INSTRUMENTS : ALIGNMENT DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12924886
MDR Text Key281675050
Report Number1818910-2021-27102
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2307-95-000
Device Catalogue Number230795000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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