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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 SM 16MM LPS AND S-ROM : KNEE TIBIAL INSERT

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DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS SM 16MM LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Catalog Number 198727216
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Synovitis (2094); No Code Available (3191)
Event Date 01/01/2020
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. Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided. 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. Corrective action was not indicated.
 
Event Description
Patient of (b)(4) will undergo another revision of right knee in early (b)(6) 2020 because of unknown reason. Doi: (b)(6) 2016. Dor (first revision, (b)(4)): (b)(6) 2019. Dor (second revision, (b)(4)): (b)(6) 2020.
 
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Brand NameLPS UNIV TIB HIN INS SM 16MM
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)
DEPUY RAYNHAM - 1219655
325 paramount drive
raynham MA 02767 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9865279
MDR Text Key187870832
Report Number1818910-2020-08814
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
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 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2022
Device Catalogue Number198727216
Device Lot NumberH43099
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 Received09/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2017
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: 03/23/2020 Patient Sequence Number: 1
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