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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN TIB STM 5 DEG SZ G L PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PSN TIB STM 5 DEG SZ G L PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Pulmonary Embolism (1498)
Event Date 03/12/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00102, 3007963827-2019-00103, 3007963827-2019-00104, and 0002648920-2019-00269. Concomitant medical devices: psn fem ps cmt ccr std sz 10 l catalog#: 42500606801 lot#: 63983030, psn asf ps 11mm ve l 10-12 gh catalog#: 42512401011 lot#: 64065570, psn all poly pat ply 35mm catalog#: 42540000035 lot#: 64291028. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that patient underwent left total knee arthroplasty. Subsequently, the patient experienced a pulmonary embolism eleven days after the procedure, which required hospitalization. No revision procedure has been reported.

 
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Brand NamePSN TIB STM 5 DEG SZ G L
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 Key8515163
MDR Text Key141965407
Report Number3007963827-2019-00103
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type STUDY
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532007901
Device LOT Number64075190
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/06/2018
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: 04/15/2019 Patient Sequence Number: 1
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