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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 -2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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DEPUY ORTHOPAEDICS INC US ASPHERE M SPEC 12/14 40 -2; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS Back to Search Results
Model Number 1365-04-100
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Codes Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)
Date of Event 07/23/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that the cup, screw, liner, and head were revised.The cup was vertical.Screw information not available.Doi: (b)(6) 2010; dor: (b)(6) 2019, (left hip).
 
Additional Manufacturer Narrative
Product complaint # (b)(6).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
ASPHERE M SPEC 12/14 40 -2
Common Device Name
ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9889839
Report Number1818910-2020-09481
Device Sequence Number3418993
Product Code JDI
UDI-Device Identifier10603295032953
UDI-Public10603295032953
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K082585
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2019
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number1365-04-100
Device Catalogue Number136504100
Device Lot Number3195774
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/10/2020
Supplement Date Received by Manufacturer07/22/2020
Initial Report FDA Received Date03/27/2020
Supplement Report FDA Received Date07/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
APEX HOLE ELIM POSITIVE STOP; ASPHERE M SPEC 12/14 40 -2; PINN CAN BONE SCREW 6.5MMX20MM; PINN SECTOR W/GRIPTION 56MM; PINNACLE MTL INS NEUT40IDX56OD; SUMMIT DUOFIX TAP SZ6 HI OFF
Outcome Attributed to Adverse Event Required Intervention;
Patient Age55 YR
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