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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Thrombosis (2100)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: persona femur cemented posterior stabilized (ps), catalog # 42500605802, lot # 63982839; persona stemmed tibia, catalog # 42532006702, lot # 64078277; persona all poly patella, catalog # 42540000029, lot # 64214476. Customer has indicated that the product will not be returned because it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filled for this event: 3007963827-2019-00069, 3007963827-2019-00070, 0002648920-2019-00193. Remains implanted.

 
Event Description

It was reported that the patient underwent a right knee arthroplasty. Subsequently, the patient was experiencing deep vein thrombosis one month post operative. No revision procedure has been reported to date. Attempt for further information has been made, but no further information has been provided.

 
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Brand NamePERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8418000
MDR Text Key138708373
Report Number3007963827-2019-00071
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522400410
Device LOT Number64207001
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/04/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 03/13/2019 Patient Sequence Number: 1
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