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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN MED RT 71X66 LPS AND S-ROM : KNEE FEMORAL

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DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN MED RT 71X66 LPS AND S-ROM : KNEE FEMORAL Back to Search Results
Model Number 62-3401R
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
(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.
 
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Brand NameSROM NRHFEM W/PIN MED RT 71X66
Type of DeviceLPS AND S-ROM : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12235661
MDR Text Key263838990
Report Number1818910-2021-16218
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K896048
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 Number62-3401R
Device Catalogue Number623401R
Device Lot NumberHG7954
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 Manufactured09/22/2017
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
Treatment
LPS UNIV TIB HIN INS MED 12MM; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 37MM; SROM NRH DIST AUG XS/S/MD 10MM; SROM NRHFEM W/PIN MED RT 71X66; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 115X16MM FLUTED
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