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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX56OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-456
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/24/2021
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.
 
Event Description
It was reported that the surgeon requested poly liner for revision of pinnacle metal on metal liner and stem replacement in anticipation of loosening due to increase ion levels. Tissues appeared normal color and stem well fixed from point of view throughout procedure. No surgical delay. Doi: (b)(6) 2009; dor: (b)(6) 2021; unknown affected side.
 
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Brand NamePINNACLE MTL INS NEUT40IDX56OD
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)
LEEDS MFG & MATERIAL WAREHOUSE
st anthonys road
leeds LS11 8DT
UK LS11 8DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581
6107428552
MDR Report Key11638805
MDR Text Key244596859
Report Number1818910-2021-07489
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2014
Device Model Number1218-87-456
Device Catalogue Number121887456
Device Lot Number3004573
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/08/2021 Patient Sequence Number: 1
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