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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 36 +5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 36 +5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-52-100
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); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Event Date 11/09/2021
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 that the surgeon revised the 54 ultamet liner due to hip pain & metallosis. Surgeon removed the metal liner and replaced with an altrx liner. Doi: (b)(6) 2010 - dor: (b)(6) 2021 (right hip).
 
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Brand NameASPHERE M SPEC 12/14 36 +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)
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 Key12861375
MDR Text Key281147717
Report Number1818910-2021-26171
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1365-52-100
Device Catalogue Number136552100
Device Lot Number3056293
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2010
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: 11/23/2021 Patient Sequence Number: 1
Treatment
ASPHERE M SPEC 12/14 36 +5; PINNACLE MTL INS NEUT36IDX54OD
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