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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA XLK CVD PLUS INS 4 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIGMA XLK CVD PLUS INS 4 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 97-0460
Date of Event 11/03/2020
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's knee was revised to address issue with range of motion and loosening of the tibial component at the cement to implant interface.Cement manufacturer is unknown.Doi: (b)(6) 2015; dor: (b)(6) 2020; left 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.
 
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Brand Name
SIGMA XLK CVD PLUS INS 4 8MM
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 Key10858105
Report Number1818910-2020-24896
Device Sequence Number11749627
Product Code JWH
UDI-Device Identifier10603295250609
UDI-Public10603295250609
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
K040166
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
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) 11/03/2020
1 Device 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 Number97-0460
Device Catalogue Number970460
Device Lot Number706088
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/03/2020
Supplement Date Received by Manufacturer12/15/2020
Initial Report FDA Received Date11/18/2020
Supplement Report FDA Received Date12/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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