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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-354
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Sepsis (2067); Swelling (2091); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 04/12/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pinnacle claim submission form and medical records received. After review of medical records, the patient was revised to address sepsis and pain. Patient complains of decreased range of motion and tenderness. Approximately 50 ml of gross purulence was encountered upon incision. Doi: (b)(6) 2009. Dor: (b)(6) 2018, (left hip).
 
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Brand NamePINNACLE MTL INS NEUT36IDX54OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopedics drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9109839
MDR Text Key162835141
Report Number1818910-2019-105919
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/30/2014
Device Model Number1218-87-354
Device Catalogue Number121887354
Device Lot Number2971857
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 Received03/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/24/2019 Patient Sequence Number: 1
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