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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 2 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 2 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 101204020
Medical Device Problem Code Corroded (1131)
Health Effect - Clinical Codes Foreign Body Reaction (1868); Necrosis (1971); Osteolysis (2377); No Code Available (3191)
Date of Event 06/11/2019
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
Clinical notification received for right hip revision to address adverse local tissue reaction.Doi: (b)(6) 2009; dor: (b)(6) 2019, (right hip).
 
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Brand Name
TRI-LOCK BPS SZ 2 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 Key8869692
Report Number1818910-2019-100327
Device Sequence Number335159
Product Code KWA
UDI-Device Identifier10603295000730
UDI-Public10603295000730
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K073570
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/03/2019
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 Catalogue Number101204020
Device Lot NumberDS1BM1
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/18/2019
Initial Report FDA Received Date08/07/2019
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
PINNACLE SECTOR II CUP 56MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age66 YR
Patient Weight93
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