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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anxiety (2328); Test Result (2695); No Code Available (3191)
Event Date 06/25/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Asr claim letter (italian) record received. Awaiting for english translation. Once available this complaint will be updated.
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
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 drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9991149
MDR Text Key188741281
Report Number1818910-2020-11200
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
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 Initial

Patient Treatment Data
Date Received: 04/23/2020 Patient Sequence Number: 1
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