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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF HIP FEMORAL STEM/SLEEVE

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DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number 157011120
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330)
Event Date 07/28/2015
Event Type  Injury  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

 
Event Description

Litigation papers allege pain, discomfort, inflammation, and large amounts of toxic cobalt-chromium metal ions and particles.

 
Manufacturer Narrative

No device associated with this report was received for examination. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. 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. Corrective action was not indicated. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
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Brand NameSUMMIT POR TAPER SZ6 HI OFF
Type of DeviceHIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key5007875
MDR Text Key23176607
Report Number1818910-2015-28255
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK001991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup,Followup
Report Date 07/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/12/2017
Device Catalogue Number157011120
Device LOT NumberBJ3ET1000
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 Received11/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/15/2007
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: 08/17/2015 Patient Sequence Number: 1
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