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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 PFC SIGMARP CV TB/IN S3 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDIC INC, 1818910 PFC SIGMARP CV TB/IN S3 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 962032
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Pain (1994); Not Applicable (3189)
Date of Event 05/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 knee pain developed in 2017.Femur and tibia was well fixed and aligned properly.Insert was worn in posterior medial area.Doi: 2008; dor: (b)(6) 2018; right knee.
 
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.
 
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Brand Name
PFC SIGMARP CV TB/IN S3 12.5
Common Device Name
SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key7554084
Report Number1818910-2018-60888
Device Sequence Number1261576
Product Code NJL
UDI-Device Identifier10603295240754
UDI-Public10603295240754
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 05/04/2018
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 Number962032
Device Lot Number2583089
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/04/2018
Supplement Date Received by Manufacturer06/27/2018
Initial Report FDA Received Date05/30/2018
Supplement Report FDA Received Date07/03/2018
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 Age57 YR
Patient Weight97
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