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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 40 +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 40 +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-05-100
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); 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 04/14/2021
Event Type  Injury  
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.
 
Event Description
It was reported as "revised a pinnacle metal on metal to a new cup, poly liner and a ceramic ts head. Original cup was malpositioned. A lot of metallosis in the joint. High cobalt/ chromium levels". Doi: (b)(6) 2009. Dor: (b)(6) 2021; right hip.
 
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Brand NameASPHERE M SPEC 12/14 40 +1.5
Type of DeviceARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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 Key11743897
MDR Text Key248835294
Report Number1818910-2021-09134
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1365-05-100
Device Catalogue Number136505100
Device Lot Number3000510
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2009
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: 04/29/2021 Patient Sequence Number: 1
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