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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

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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 Problems Fracture (1260); Device Dislodged or Dislocated (2923)
Patient Problems Hematoma (1884); Pain (1994); Swelling (2091); No Code Available (3191)
Event Date 02/07/2020
Event Type  Injury  
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 Description
Revision of unknown parts of a lps knee system because of inlay failure.
 
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Brand NameLPS UNIV TIB HIN INS XSM 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
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9908097
MDR Text Key186805808
Report Number1818910-2020-09815
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
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 02/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Model Number1987-27-112
Device Catalogue Number198727112
Device Lot NumberH20956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2016
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: 03/31/2020 Patient Sequence Number: 1
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