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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA XLKCVD PLUS INS 2.5 15MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIGMA XLKCVD PLUS INS 2.5 15MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 970443
Medical Device Problem Code Fitting Problem (2183)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/23/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device revealed evidence confirming the reported event.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.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
When the insert should be placed, the insert did not get fixed in i2locking part.
 
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Brand Name
SIGMA XLKCVD PLUS INS 2.5 15MM
Common Device Name
SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8054576
Report Number1818910-2018-75038
Device Sequence Number16634208
Product Code JWH
UDI-Device Identifier10603295250517
UDI-Public10603295250517
Combination Product (Y/N)N
Initial Reporter CountrySW
PMA/510(K) Number
K040166
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/06/2018
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 Number970443
Device Lot Number669780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/06/2018
Initial Report FDA Received Date11/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
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