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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL SLEEVE UNIPOLAR

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DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL SLEEVE UNIPOLAR Back to Search Results
Catalog Number UNK HIP FEMORAL SLEEVE UNIPOLA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Discomfort (2330)
Event Date 12/15/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided. The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
Event Description
Removal of unipolar implant. Patient felt discomfort. Doi: unk - dor: (b)(6) 2020; affected side: unk hip.
 
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Brand NameUNK HIP FEMORAL SLEEVE UNIPOLAR
Type of DeviceFEMORAL SLEEVE
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
6107428552
MDR Report Key11117047
MDR Text Key225095158
Report Number1818910-2021-00187
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL SLEEVE UNIPOLA
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 Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/05/2021 Patient Sequence Number: 1
Treatment
UNK SPACER; UNKNOWN HIP FEMORAL HEAD
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