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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM*STM ST,36+8L NK,18X13X160 S-ROM HIP SYSTEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS, INC. 1818910 SROM*STM ST,36+8L NK,18X13X160 S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 523418
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Spasm(s) (1966); Pain (1994); Weakness (2145); Discomfort (2330); Test Result (2695); No Code Available (3191)
Event Date 04/04/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). Attorney.
 
Event Description
Litigation alleges severe pain, spasm, and weakness.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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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Type of DeviceS-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
CORK MFG & MATERIAL WAREHOUSE
loughbeg ringaskiddy
cork IN 46582 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46582-XXXX
6103142063
MDR Report Key8069114
MDR Text Key127091103
Report Number1818910-2018-75406
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number523418
Device Lot Number1142115
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2004
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: 11/14/2018 Patient Sequence Number: 1
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