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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 55; BONE SCREWS AND PINS : SCREWS
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DEPUY ORTHOPAEDICS INC US 5.0MM DIA TPRD HD PER SCRW 55; BONE SCREWS AND PINS : SCREWS Back to Search Results
Model Number 1257-55-000
Medical Device Problem Codes Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 10/05/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The patient was revised to address migration and loosening of the cup at the bone to implant interface.Cancer patient.Converted to tri-flange.Proximal femur and segment removed to re-establish leg length.Doi: (b)(6) 2018, dor: (b)(6) 2021 affected side: 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, post market surveillance, 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.
 
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Brand Name
5.0MM DIA TPRD HD PER SCRW 55
Common Device Name
BONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12646627
Report Number1818910-2021-22847
Device Sequence Number16572309
Product Code JDI
UDI-Device Identifier10603295019923
UDI-Public10603295019923
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 Year2018
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source Health Professional,Company Representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/05/2021
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? Yes
Operator of Device Health Professional
Device Model Number1257-55-000
Device Catalogue Number125755000
Device Lot Number498821
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/05/2021
Supplement Date Received by Manufacturer11/16/2021
Initial Report FDA Received Date10/18/2021
Supplement Report FDA Received Date11/22/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured03/20/2014
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
5.0MM DIA TPRD HD PER SCRW 55; 5.0MM DIA TPRD HD PER SCRW 55; DELTA CER HEAD 12/14 28MM +1.5; LPS PROX FEM STD BODY 15DEG LT; LPS SEGMENTAL COMPONENT 85MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX40MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN CAN BONE SCREW 6.5MMX50MM; PINN CAN BONE SCREW 6.5MMX55MM; PINN LNR CON +4 NEUT 28IDX48OD; PINN REVISION W/GRIPTION 54MM; 5.0MM DIA TPRD HD PER SCRW 55; 5.0MM DIA TPRD HD PER SCRW 55; DELTA CER HEAD 12/14 28MM +1.5; LPS PROX FEM STD BODY 15DEG LT; LPS SEGMENTAL COMPONENT 85MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX40MM; PINN CAN BONE SCREW 6.5MMX45MM; PINN CAN BONE SCREW 6.5MMX50MM; PINN CAN BONE SCREW 6.5MMX55MM; PINN LNR CON +4 NEUT 28IDX48OD; PINN REVISION W/GRIPTION 54MM
Outcome Attributed to Adverse Event Required Intervention;
Patient SexFemale
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