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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121732050
Device Problems Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
Event Date 03/08/2012
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). Occupation: attorney.

 
Event Description

Litigation alleges the patient suffers from inflammation, pain, discomfort, a limp, and large amounts of toxic cobalt-chromium metal ions and particles to be released into the blood, tissue, and bone. Update 03/19/2015- pfs and medical records received. After review of the medical records for mdr reportability, the revision operative note indicated pain and metallosis. No labs were provided for the alleged high metal ions. The complaint was updated on: 03/30/2015. Update ad 9 oct 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 stroke and heart attack. Added patient initial, hospital, law firm. Cup and screw was added due to ppf allegation. Doi: (b)(6) 2009. Dor: (b)(6) 2012, (right hip).

 
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, a follow-up medwatch will be filed as appropriate.

 
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Brand NamePINN SECTOR W/GRIPTION 50MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
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 19380-0988
6107428552
MDR Report Key9081277
Report Number1818910-2019-105128
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121732050
Device LOT NumberDH7B41000
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 Received12/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/10/2009
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: 09/18/2019 Patient Sequence Number: 1
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