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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 5 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 5 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 158125112
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 06/08/2018
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 to address stiffness and pain.Surgeon cleaned up the joint space and put in a new poly.Doi: (b)(6) 2006; dor: (b)(6) 2018; left knee.
 
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary : no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
SIGMA STAB XLK INS 5 12.5MM
Common Device Name
SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7655135
Report Number1818910-2018-63655
Device Sequence Number16185233
Product Code JWH
UDI-Device Identifier10603295064671
UDI-Public10603295064671
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K040166
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/08/2018
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? No
Operator of Device Health Professional
Device Catalogue Number158125112
Device Lot NumberYS6B61000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/08/2018
Supplement Date Received by Manufacturer07/26/2018
Initial Report FDA Received Date07/02/2018
Supplement Report FDA Received Date08/02/2018
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 Age63 YR
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