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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA/RD/DOME PAT 3PEG,38; SIGMA KNEE PRIMARY : KNEE PATELLA
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DEPUY ORTHOPAEDICS INC US PFC*SIGMA/RD/DOME PAT 3PEG,38; SIGMA KNEE PRIMARY : KNEE PATELLA Back to Search Results
Model Number 96-0112
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Adhesion(s) (1695); Pain (1994)
Date of Event 10/11/2019
Type of Reportable Event Serious Injury
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.(b)(4).
 
Event or Problem Description
It was reported that patient continued to have issues with instability and pain, as well as adhesion.Doi: (b)(6) 2019.Dor: unknown left knee.
 
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Common Device Name
SIGMA KNEE PRIMARY : KNEE PATELLA
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9752250
Report Number1818910-2020-05956
Device Sequence Number3029427
Product Code JWH
UDI-Device Identifier10603295232681
UDI-Public10603295232681
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K884796
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/02/2019
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 Model Number96-0112
Device Catalogue Number960112
Device Lot NumberD13031832
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/10/2020
Initial Report FDA Received Date02/25/2020
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;
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