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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 SUMMIT HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1570-11-120
Device Problems Biocompatibility; Adverse Event Without Identified Device or Use Problem
Event Date 08/23/2010
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. Occupation: attorney. (b)(4).

 
Event Description

Medical records received from legal indicate that the patient was revised because of pain with heterotopic ossification. Update ad 9 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record. In addition to what were previously alleged, ppf alleges elevated metal ions. Added stem due to this allegation. Account name, facility name, age, birth date, associated contacts, patient harms, products expiration and udi were also added. Doi: (b)(6) 2010 - dor: (b)(6) 2010, (left hip).

 
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Brand NameSUMMIT POR TAPER SZ6 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 INT'L LTD. 8010379
st anthonys road
leeds LS11 8DT
UK  LS11 8DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6107428552
MDR Report Key8738998
Report Number1818910-2019-96910
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2020
Device MODEL Number1570-11-120
Device Catalogue Number157011120
Device LOT NumberUNKNOWN
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 Received02/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/31/2010
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: 06/27/2019 Patient Sequence Number: 1
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