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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COM DSTL AUG 5MM LG LT; LCS COMPLETE : KNEE FEMORAL ACCESSORY
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DEPUY ORTHOPAEDICS INC US LCS COM DSTL AUG 5MM LG LT; LCS COMPLETE : KNEE FEMORAL ACCESSORY Back to Search Results
Model Number 1294-26-063
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 04/27/2020
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 possible infection and loosening of the femoral augments at the bone to implant interface.Doi: unknown.Dor: (b)(6) 2020; left knee.
 
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
LCS COM DSTL AUG 5MM LG LT
Common Device Name
LCS COMPLETE : KNEE FEMORAL ACCESSORY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10038972
Report Number1818910-2020-11871
Device Sequence Number2956516
Product Code NJL
UDI-Device Identifier10603295025191
UDI-Public10603295025191
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/27/2020
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 Number1294-26-063
Device Catalogue Number129426063
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/27/2020
Supplement Date Received by Manufacturer05/12/2020
Initial Report FDA Received Date05/08/2020
Supplement Report FDA Received Date05/13/2020
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 LG LT; LCS COM POST AUG 5MM LG; LCS COM POST AUG 5MM LG; LCS COMP REV INS LG 10MM; UNKNOWN KNEE FEMORAL; LCS COM DSTL AUG 5MM LG LT; LCS COM POST AUG 5MM LG; LCS COM POST AUG 5MM LG; LCS COMP REV INS LG 10MM; UNKNOWN KNEE FEMORAL
Outcome Attributed to Adverse Event Required Intervention;
Patient Age87 YR
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