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 14MM; 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 14MM; LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-114
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 07/27/2021
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 due to infected knee.Washout and poly exchange was done.Doi: unknown, dor: (b)(6) 2021, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LPS UNIV TIB HIN INS XSM 14MM
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 Key12336837
Report Number1818910-2021-18073
Device Sequence Number2826185
Product Code KRO
UDI-Device Identifier10603295079408
UDI-Public10603295079408
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K091453
Number of Events Summarized1
Summary Report (Y/N)N
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) 07/27/2021
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 Number1987-27-114
Device Catalogue Number198727114
Device Lot NumberBFAOVXP
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/27/2021
Supplement Date Received by Manufacturer08/25/2021
Initial Report FDA Received Date08/18/2021
Supplement Report FDA Received Date08/26/2021
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 UNIV TIB HIN INS XSM 14MM; LPS XX-SM HINGE PIN; LPS UNIV TIB HIN INS XSM 14MM; LPS XX-SM HINGE PIN
Outcome Attributed to Adverse Event Required Intervention;
-
-