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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMP RPS INS STD+ 15MM; LCS COMPLETE : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US LCS COMP RPS INS STD+ 15MM; LCS COMPLETE : KNEE TIBIAL INSERT Back to Search Results
Model Number 1294-16-515
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Adhesion(s) (1695)
Date of Event 08/23/2021
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 in the left knee due to arthrofibrosis.Removed femur, insert and tray.Original dos is unknown.Doi: unknown, dor: (b)(6) 2021, left knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
LCS COMP RPS INS STD+ 15MM
Common Device Name
LCS COMPLETE : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12473742
Report Number1818910-2021-20099
Device Sequence Number5088315
Product Code NJL
UDI-Device Identifier10603295023265
UDI-Public10603295023265
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/23/2021
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? No
Operator of Device Health Professional
Device Model Number1294-16-515
Device Catalogue Number129416515
Device Lot NumberBFA06JD
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/23/2021
Supplement Date Received by Manufacturer10/11/2021
Initial Report FDA Received Date09/15/2021
Supplement Report FDA Received Date10/12/2021
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
BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); LCS COM RPSFLEX FEM CEM L STD+; LCS COMP RPS INS STD+ 15MM; MBT CEM TIBIAL TRAY SZ3; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); LCS COM RPSFLEX FEM CEM L STD+; LCS COMP RPS INS STD+ 15MM; MBT CEM TIBIAL TRAY SZ3
Outcome Attributed to Adverse Event Required Intervention;
Patient Age71 YR
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