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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COMPLETE M/B PAT POR STD+; LCS COMPLETE : KNEE PATELLA
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DEPUY ORTHOPAEDICS INC US LCS COMPLETE M/B PAT POR STD+; LCS COMPLETE : KNEE PATELLA Back to Search Results
Catalog Number 129409650
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Codes Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event 07/29/2019
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.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.
 
Event or Problem Description
The patient was revised to address loosening of the patella at the bone to implant interface.The patella was replaced with a dome patella.Doi: (b)(6) 2009; dor: (b)(6) 2019, right knee.
 
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Brand Name
LCS COMPLETE M/B PAT POR STD+
Common Device Name
LCS COMPLETE : KNEE PATELLA
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8907492
Report Number1818910-2019-101482
Device Sequence Number2396801
Product Code NJL
UDI-Device Identifier10603295022657
UDI-Public10603295022657
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
P830055
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) 07/29/2019
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 Number129409650
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/29/2019
Initial Report FDA Received Date08/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Weight71
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