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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 3 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 3 HI OFFSET TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Model Number 1012-14-030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Inflammation (1932); Pain (1994); Ambulation Difficulties (2544); Physical Asymmetry (4573); Swelling/ Edema (4577)
Event Date 05/27/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the revision was due to displacement and fracture of poly liner. Doi: (b)(6) 2019, dor: (b)(6) 2020, affected side: left hip.
 
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Brand NameTRI-LOCK BPS SZ 3 HI OFFSET
Type of DeviceTRILOCK HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12712502
MDR Text Key278815272
Report Number1818910-2021-23912
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1012-14-030
Device Catalogue Number101214030
Device Lot NumberJ2883W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/28/2021 Patient Sequence Number: 1
Treatment
ALTRX +4 10D 36IDX52OD; DELTA CER HEAD 12/14 36MM +1.5; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 52MM; TRI-LOCK BPS SZ 3 HI OFFSET
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