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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887458
Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Foreign Body Reaction (1868); Pain (1994); Discomfort (2330); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Event Date 06/03/2016
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pinnacle litigation records received. Litigation alleges severe pain, discomfort and tested metal ions well above an acceptable range. Patient underwent a painful, complex and risky surgery to removed the device. During the revision, an extended trochanteric osteotomy was preformed. On (b)(6) 2016 the patient succumbed due in part from complications of the revision surgery. Doi: (b)(6) 2009 : dor: (b)(6) 2016; (right hip). Deceased patient.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. Device history lot: null. Device history batch: null. Device history review: null. 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 NamePINNACLE MTL INS NEUT40IDX58OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
FINSBURY ORTHOPAEDICS LIMITED
13 mole business park
randalls road
leatherhead, surrey IN 46582 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6103142063
MDR Report Key7590651
MDR Text Key110714852
Report Number1818910-2018-61836
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2013
Device Catalogue Number121887458
Device Lot Number2548857
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 Received05/15/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/13/2008
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: 06/12/2018 Patient Sequence Number: 1
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