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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 157011110
Device Problems Biocompatibility; Adverse Event Without Identified Device or Use Problem
Event Date 09/12/2014
Event Type  Injury  
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. Initial reporter occupation: attorney. (b)(4).

 
Event Description

Litigation alleges patient suffers from pain, discomfort, difficulty ambulating, and metallosis. Update ad 21 aug 2018: (b)(4) been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record. In addition to what where previously alleged, ppf alleges metal wear and elevated metal ions.

 
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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Brand NameSUMMIT POR TAPER SZ5 HI OFF
Type of DeviceSUMMIT HIP STEM : HIP 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 drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key8687897
Report Number1818910-2019-95722
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2017
Device Catalogue Number157011110
Device LOT NumberB53FG1000
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 Received11/18/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/14/2007
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: 06/11/2019 Patient Sequence Number: 1
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