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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S(PS)BOX TRL,SZ2.5; KNEE INSTRUMENT : FEMORAL TRIALS
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/S(PS)BOX TRL,SZ2.5; KNEE INSTRUMENT : FEMORAL TRIALS Back to Search Results
Catalog Number 961048
Medical Device Problem Code Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
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
Stuck together.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a duplicate report of 1818910-2019-112123.1818910-2019-112166 is being retracted as it is a report duplication.1818910-2019-112123 will be kept for investigation purposes.
 
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Common Device Name
KNEE INSTRUMENT : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9240242
Report Number1818910-2019-112166
Device Sequence Number145874
Product Code LXH
UDI-Device Identifier10603295234760
UDI-Public10603295234760
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number961048
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/04/2019
Supplement Date Received by Manufacturer10/30/2019
Initial Report FDA Received Date10/25/2019
Supplement Report FDA Received Date11/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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