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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 Inflammation (1932); Pain (1994); Pocket Erosion (2013); Impaired Healing (2378); Swelling/ Edema (4577)
Event Date 04/17/2019
Event Type  Injury  
Event Description
Unfiled claim and pinnacle mom medical records received. After review of the medical records the patient was revised to address pain and failure of mechanical right total hip arthroplasty. Operative findings suggestion of trochanteric bursitis without presence of pseudotumor. Operative note reported some attenuation in the fascia right trochanter. Previous abductor repair not completely healed, there was new erosion and large amount of fluid. Pathology report evidence of trochanteric bursitis. Doi: (b)(6) 2011; dor: (b)(6) 2019; right hip.
 
Manufacturer Narrative
Product complaint # (b)(4). 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 NEUT36IDX54OD
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 dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12916485
MDR Text Key281595926
Report Number1818910-2021-26926
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2015
Device Model Number1218-87-354
Device Catalogue Number121887354
Device Lot Number3149034
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/02/2021 Patient Sequence Number: 1
Treatment
AML LG STATURE 15.0MM; ASPHERE M SPEC 12/14 36 +5; PINN SECTOR W/GRIPTION 54MM; PINNACLE MTL INS NEUT36IDX54OD
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