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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 23MM LPS AND S-ROM : KNEE TIBIAL INSERT

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DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 23MM LPS AND S-ROM : KNEE TIBIAL INSERT Back to Search Results
Model Number 1987-27-123
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Joint Laxity (4526)
Event Date 11/26/2020
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
Total knee replacement (revision) was needed because after falling (last year), patient´s knee started to be unstable in lateral and medial flexion and extension. Patient declared she did not feel her knee the same as before, surgeon explored her and decided to plan revision surgery. Tibial insert was indeed slightly mobilized, the spine was moving up and down and laterally.
 
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Brand NameLPS UNIV TIB HIN INS XSM 23MM
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 ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11012488
MDR Text Key221561985
Report Number1818910-2020-26987
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeSP
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 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1987-27-123
Device Catalogue Number198727123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/15/2020 Patient Sequence Number: 1
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