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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-352
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Synovitis (2094); Osteolysis (2377); No Code Available (3191)
Event Date 02/05/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided. (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
Pinnacle medical record received. After review of medical record, patient was revised to address pain and synovitis. Revision notes stated that a bulging thickened hip capsule was noted. A 10cc of dark red particulate fluid was removed from the joint and dark red brown effusion was evacuated. The head and liner were removed. There was moderate amount of trunnionosis and corrosion of the femoral trunnion. Operative findings noted metallosis with mark effusion, large pseudotumor, and osteolysis. Blood cobalt levels were increasing but less than 7 ppb. Clinic visits noted erosions of proximal femur. Doi: (b)(6) 2006 - dor: (b)(6) 2020 (left hip).
 
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Brand NamePINNACLE MTL INS NEUT36IDX52OD
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)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10663094
MDR Text Key211139667
Report Number1818910-2020-21959
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K003523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2011
Device Model Number1218-87-352
Device Catalogue Number121887352
Device Lot Number2151734
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/19/2006
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: 10/12/2020 Patient Sequence Number: 1
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