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 LPS UNIV TIB HIN INS XXSM 16MM; LPS AND S-ROM : 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 LPS UNIV TIB HIN INS XXSM 16MM; LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-016
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 12/18/2020
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
The patient was revised due to femoral side dislocation.Original surgery was on (b)(6) 2020 second revision was on (b)(6) 2020 captured in (b)(4).Doi: (b)(6) 2020, doi: (b)(6) 2020 (tibial insert and segment), dor: (b)(6) 2020, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LPS UNIV TIB HIN INS XXSM 16MM
Common Device Name
LPS AND S-ROM : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11118110
Report Number1818910-2021-00267
Device Sequence Number14465750
Product Code KRO
UDI-Device Identifier10603295079354
UDI-Public10603295079354
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K091453
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
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) 12/18/2020
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? Yes
Operator of Device Health Professional
Device Model Number1987-27-016
Device Catalogue Number198727016
Device Lot NumberJ79W98
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/18/2020
Supplement Date Received by Manufacturer02/05/2021
Initial Report FDA Received Date01/05/2021
Supplement Report FDA Received Date02/08/2021
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
LPS DISTAL FEM COMP XXSM RT; LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 65MM; LPS XX-SM HINGE PIN; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 115X14MM FLUTED; LPS DISTAL FEM COMP XXSM RT; LPS FEM TO SLEEVE ADAPTER +5; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 65MM; LPS XX-SM HINGE PIN; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 115X14MM FLUTED
Outcome Attributed to Adverse Event Required Intervention;
Patient Age65 YR
-
-