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

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DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 40 +5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-06-100
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Event Date 03/22/2021
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
Revision completed due to concerns of elevated metal ion possibility. Patient revised to a ceramic head ball. Doi: (b)(6) 2008. Dor: (b)(6) 2021. Right hip.
 
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Brand NameASPHERE M SPEC 12/14 40 +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
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14073549
MDR Text Key288987503
Report Number1818910-2022-06476
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1365-06-100
Device Catalogue Number136506100
Device Lot Number2932405
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2009
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: 04/11/2022 Patient Sequence Number: 1
Treatment
UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL STEM
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