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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-358
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Necrosis (1971); Pain (1994); No Code Available (3191)
Event Date 11/30/2010
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter occupation: lawyer. (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
Unf and medical records received. After review of medical records, patient was revised to address severe left hip pain. Mri showed a heavy burden of intracapsular particles. Revision notes stated that the patient was noted to have a significant scar tissue, and deep to the fascia, there were large areas of avascular nonviable scar tissue. Large areas of avascular necrotic tissue were removed. The patient was noted to have a large bare areas overlying the greater trochanter and the lateral aspect of the proximal femur. The granulation tissue was also identified around the acetabular component. Extensive black material around the trunnion was noted. It appeared consistent with corrosion. Doi: (b)(6) 2007. Dor: (b)(6) 2010, (left hip). Doi: (b)(6) 2006, (head and liner). This pc is for the second revision of the left hip. Please see (b)(4) for the first revision and (b)(4) for the right hip.
 
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Brand NamePINNACLE MTL INS NEUT36IDX58OD
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 Key9928761
MDR Text Key186744170
Report Number1818910-2020-10241
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003523
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/30/2011
Device Model Number1218-87-358
Device Catalogue Number121887358
Device Lot Number2127424
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 Received04/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2006
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: 04/06/2020 Patient Sequence Number: 1
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