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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 1961-92-042
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event 01/26/2021
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
Study:(b)(6).Clinical notification received for revision of left total knee to address femoral osteolysis.Date of implantation: (b)(6) 2019, date of revision: (b)(6) 2021, (left knee).Treatment: femur and tibial insert revised.Additional information received: on (b)(6) 2019, the patient underwent a primary left knee arthroplasty due to osteoarthritis.Depuy products were implanted.On (b)(6) 2021, the patient underwent a left knee revision to address pain, discomfort, edema, instability, walking difficulty, and osteolysis.Pre-operatively the surgeon suspected femoral component was loose, however, the revision operative note confirmed the femoral component was well-fixed.The surgeon noted minimal bone loss to the femur.The tibial insert and femoral component were revised.The tibial tray and patellar component were retained.There were no indicated intra-operative complications.
 
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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
SIG RP AOX CRV INS SZ4 12.5
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 Key11371972
Report Number1818910-2021-03719
Device Sequence Number934689
Product Code NJL
UDI-Device Identifier10603295076216
UDI-Public10603295076216
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/05/2021
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 Number1961-92-042
Device Catalogue Number196192042
Device Lot Number9148586
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/05/2021
Supplement Date Received by Manufacturer03/30/2021
Initial Report FDA Received Date02/24/2021
Supplement Report FDA Received Date04/01/2021
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
DEPUY CMW 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/R NPOR FEM LT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38; DEPUY CMW 1 40G; DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/R NPOR FEM LT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,38
Outcome Attributed to Adverse Event Required Intervention;
Patient Age74 YR
Patient Weight82
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