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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COM POST AUG 5MM STD+; LCS COMPLETE : KNEE FEMORAL ACCESSORY
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DEPUY ORTHOPAEDICS INC US LCS COM POST AUG 5MM STD+; LCS COMPLETE : KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1294-27-050
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 03/01/2021
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
The patient was revised due to infection.All implants were removed.Doi: (b)(6) 2019; dor: (b)(6) 2021; right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
LCS COM POST AUG 5MM STD+
Common Device Name
LCS COMPLETE : KNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11456054
Report Number1818910-2021-04874
Device Sequence Number3762765
Product Code NJL
UDI-Device Identifier10603295025368
UDI-Public10603295025368
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 03/01/2021
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 Number1294-27-050
Device Catalogue Number129427050
Device Lot NumberH66316
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/01/2021
Supplement Date Received by Manufacturer04/15/2021
Initial Report FDA Received Date03/10/2021
Supplement Report FDA Received Date04/18/2021
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
LCS COM DSTL AUG 5MM STD+ RT; LCS COM POST AUG 5MM STD+; LCS COM POST AUG 5MM STD+; LCS COMP RPS INS STD+ 20MM; LCS COMPLETE REVFEM CEM R STD+; MBT REV TIB TRAY SIZE 3 15MM; MBT TRAY SLEEVE POR M/L 45MM; SMARTSET GMV 40G US EO; UNIVERSAL FEM SLV DIS POR 31MM; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED
Outcome Attributed to Adverse Event Required Intervention;
Patient Age63 YR
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