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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 5.0MM DIA TPRD HD PER SCRW 45; BONE SCREWS AND PINS : SCREWS
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DEPUY ORTHOPAEDICS INC US 5.0MM DIA TPRD HD PER SCRW 45; BONE SCREWS AND PINS : SCREWS Back to Search Results
Model Number 1257-45-000
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 03/05/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).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
The cup, liner and screws were implanted during a revision procedure.It is unknown if the original implants were depuy.The patient had extensive bone loss and the failed to osseointegrate with the cup and screws that were implanted at revision (doi).A decision was made to convert to protrusio cage.Doi: (b)(6) 2021, dor: (b)(6) 2021, left hip.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot a device history record (mre) review, was not possible because the required lot code was not provided.
 
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Brand Name
5.0MM DIA TPRD HD PER SCRW 45
Common Device Name
BONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11521270
Report Number1818910-2021-05519
Device Sequence Number5513161
Product Code JDI
UDI-Device Identifier10603295019909
UDI-Public10603295019909
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K861979
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/05/2021
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? No
Operator of Device Health Professional
Device Model Number1257-45-000
Device Catalogue Number125745000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/05/2021
Supplement Date Received by Manufacturer04/13/2021
Initial Report FDA Received Date03/18/2021
Supplement Report FDA Received Date04/14/2021
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
5.0MM DIA TPRD HD PER SCRW 45.; 5.0MM DIA TPRD HD PER SCRW 50.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN LNR CON +4 NEUT 32IDX62OD.; PINN REVISION W/GRIPTION 68MM.
Outcome Attributed to Adverse Event Required Intervention;
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