• 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 MED 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 MED 12MM LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-312
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/08/2021
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
Patient was revised to treat pain, swelling, inflammation and loss of function due to loosening secondary to infection. Doi: (b)(6) 2019, dor: (b)(6) 2021, right knee.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLPS UNIV TIB HIN INS MED 12MM
Type of DeviceLPS AND S-ROM : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE RAYNHAM MFG SITE
325 paramount drive
raynham MA 02767 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12235728
MDR Text Key264067655
Report Number1818910-2021-16224
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K091453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1987-27-312
Device Catalogue Number198727312
Device Lot NumberHF8374
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/27/2021 Patient Sequence Number: 1
-
-