Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ5; SIGMA KNEE PRIMARY : KNEE FEMORAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ5; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 96-0005
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fall (1848); Joint Laxity (4526)
Date of Event 07/01/2021
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.
 
Event or Problem Description
It was reported that the patient fell and experienced instability in the knee.The doctor replaced the femur, tibia and insert with new components to stabilize the knee.Doi: (b)(6) 2013, dor: (b)(6) 2021, 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.Device history lot : no lot information available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Common Device Name
SIGMA KNEE PRIMARY : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12215380
Report Number1818910-2021-15827
Device Sequence Number19960205
Product Code JWH
UDI-Device Identifier10603295231974
UDI-Public10603295231974
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K943462
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2021
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) 07/01/2021
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 Number96-0005
Device Catalogue Number960005
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/01/2021
Supplement Date Received by Manufacturer08/17/2021
Initial Report FDA Received Date07/22/2021
Supplement Report FDA Received Date08/18/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
COMPETITOR BONE CEMENT; MBT CEM TIBIAL TRAY SZ4; PFC SIGMARP CV TB/IN S5 12.5; PFC*SIGMA C/R NPOR FEM LT SZ5; COMPETITOR BONE CEMENT; MBT CEM TIBIAL TRAY SZ4; PFC SIGMARP CV TB/IN S5 12.5; PFC*SIGMA C/R NPOR FEM LT SZ5
Outcome Attributed to Adverse Event Required Intervention;
-
-