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 XSM 12MM; 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 XSM 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-112
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 03/25/2021
Event Type  Injury  
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 Description
The patient was revised to address infection two years post-op of a distal femur replacement.Loosening also reported at mbt tibial tray and stem at bone to cement interface.Depuy cement was used.No delay to surgery reported.Doi: (b)(6) 2017, dor: (b)(6) 2021, left knee.
 
Event Description
Additional information received indicated that the hinge pin was removed and not replaced.The surgeon placed an antibiotic spacer in the knee.The femoral sleeve and stem were left implanted.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1.
 
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: 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 product and 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 XSM 12MM
Type of Device
LPS AND S-ROM : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11628952
MDR Text Key244241397
Report Number1818910-2021-07318
Device Sequence Number1
Product Code KRO
UDI-Device Identifier10603295079392
UDI-Public10603295079392
Combination Product (y/n)N
PMA/PMN Number
K091453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1987-27-112
Device Catalogue Number198727112
Device Lot NumberHF1926
Was Device Available for Evaluation? No
Date Manufacturer Received05/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LPS DISTAL FEM COMP XSM LT.; LPS FEM TO SLEEVE ADAPTER +5.; LPS UNIV TIB HIN INS XSM 12MM.; LPS XX-SM HINGE PIN.; MBT REVISION CEM TIB TRAY SZ 3.; MBT SLEEVE.; SMARTSET GHV GENTAMICIN 40G.; SMARTSET GHV GENTAMICIN 40G.; UNIVERSAL FEM SLV FUL POR 46MM.; UNIVERSAL STEM 75X16MM FLUTED.; UNIVERSAL STEM 75X16MM FLUTED.; LPS DISTAL FEM COMP XSM LT; LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XSM 12MM; LPS XX-SM HINGE PIN; MBT REVISION CEM TIB TRAY SZ 3; MBT SLEEVE; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED
Patient Outcome(s) Required Intervention;
Patient Age77 YR
-
-