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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 5 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 5 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-04-050
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 08/16/2021
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
Surgeon reported to bfarm (nca): "fracture of the hip stem at neck area." there was no surgical delay.Doi: (b)(6) 2017, dor: (b)(6) 2021, right hip.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This device was manufactured on 11-aug-2017.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 11-aug-2017.3) any anomalies or deviations identified in dhr: none.4) expiry date: 31-jul-2027.5) ifu reference: 090200701.
 
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Brand Name
TRI-LOCK BPS SZ 5 STD 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 Key12413981
Report Number1818910-2021-19196
Device Sequence Number19995794
Product Code KWA
UDI-Device Identifier10603295000761
UDI-Public10603295000761
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P070026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/16/2021
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 Number1012-04-050
Device Catalogue Number101204050
Device Lot NumberHD9807
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/16/2021
Supplement Date Received by Manufacturer09/08/2021
Initial Report FDA Received Date09/02/2021
Supplement Report FDA Received Date09/08/2021
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
ALTRX NEUT 36IDX54OD; DELTA CER HEAD 12/14 36MM +12; PINNACLE SECTOR II CUP 54MM; TRI-LOCK BPS SZ 5 STD OFFSET; ALTRX NEUT 36IDX54OD; DELTA CER HEAD 12/14 36MM +12; PINNACLE SECTOR II CUP 54MM; TRI-LOCK BPS SZ 5 STD OFFSET
Outcome Attributed to Adverse Event Required Intervention;
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