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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ5 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ5 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 157011110
Device Problem Biocompatibility
Event Date 07/08/2014
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. Device was used for treatment, not diagnosis. Initial reporter occupation: non-healthcare professional "attorney". (b)(4).

 
Event Description

Complaint description: patient has been revised address pain. Update ad 17 aug 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and implant records. In addition to what was previously alleged. Ppf alleges elevated metal ions. Added lawyer, law firm, account name and stem due to alleged elevated metal ions. Doi: (b)(6) 2007 - dor: (b)(6) 2014, (left hip).

 
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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. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380
6107428552
MDR Report Key8619284
Report Number1818910-2019-93772
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number157011110
Device LOT NumberB18E11000
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 Received11/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/26/2007
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: 05/17/2019 Patient Sequence Number: 1
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