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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 3 SIGMA KNEE PRIMARY : KNEE FEMORAL

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DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 3 SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 94-0013
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Edema (1820); No Code Available (3191)
Event Date 02/01/2020
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.

 
Event Description

Clinical adverse event received for multiple pulmonary emboli. Event is serious and is considered severe. Event is definitely not related to device and is possibly related to procedure. Date of implantation: (b)(6) 2019. Date of event (onset): (b)(6) 2020. (left knee).

 
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Brand NameSIG C/R POROCOAT FEM LT SZ 3
Type of DeviceSIGMA KNEE PRIMARY : KNEE FEMORAL
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 drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9864961
MDR Text Key184493738
Report Number1818910-2020-08794
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/25/2020
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 HEALTH PROFESSIONAL
Device MODEL Number94-0013
Device Catalogue Number940013
Device LOT NumberJ2907U
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 Received04/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/04/2019
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
Treatment
DEPUY CMW 2 20G; DEPUY CMW 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG C/R POROCOAT FEM LT SZ 3; SIG RP AOX CRV INS SZ3 12.5
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