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 SIGMA STAB XLK INS 4 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
  • 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 SIGMA STAB XLK INS 4 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 1581-24-112
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); No Code Available (3191)
Date of Event 06/22/2020
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
Patient was revised to address infected knee.Surgeon removed all components and put in cement spacer.Doi: (b)(6) 2019 dor: (b)(6) 2020 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIGMA STAB XLK INS 4 12.5MM
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 Key10222637
Report Number1818910-2020-14906
Device Sequence Number11404365
Product Code JWH
UDI-Device Identifier10603295064503
UDI-Public10603295064503
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
K040166
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 06/22/2020
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 Number1581-24-112
Device Catalogue Number158124112
Device Lot Number8975880
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/22/2020
Supplement Date Received by Manufacturer08/07/2020
Initial Report FDA Received Date07/02/2020
Supplement Report FDA Received Date08/10/2020
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
PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG MOD TIB TRAY CEM COCR 4; SIG PS CEM FEM W/LUGS LT SZ4; SIGMA STAB XLK INS 4 12.5MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG MOD TIB TRAY CEM COCR 4; SIG PS CEM FEM W/LUGS LT SZ4; SIGMA STAB XLK INS 4 12.5MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
-
-