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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 10 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 10 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-14-100
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 05/26/2020
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
It was reported that the patient was infected.Doi: (b)(6) 2019, dor: (b)(6) 2020, right side.
 
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
TRI-LOCK BPS SZ 10 HI OFFSET
Common Device Name
TRILOCK HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10137701
Report Number1818910-2020-13548
Device Sequence Number3636917
Product Code KWA
UDI-Device Identifier10603295001126
UDI-Public10603295001126
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K073570
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/26/2020
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 Number1012-14-100
Device Catalogue Number101214100
Device Lot Number560822
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/26/2020
Supplement Date Received by Manufacturer07/20/2020
Initial Report FDA Received Date06/10/2020
Supplement Report FDA Received Date07/20/2020
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
ALTRX NEUT 36IDX58OD; DLT TS CER HD 12/14 36MM +5.0; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 58MM; TRI-LOCK BPS SZ 10 HI OFFSET; ALTRX NEUT 36IDX58OD; DLT TS CER HD 12/14 36MM +5.0; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN SECTOR W/GRIPTION 58MM; TRI-LOCK BPS SZ 10 HI OFFSET
Outcome Attributed to Adverse Event Required Intervention;
Patient Age64 YR
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