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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685); Death (1802); Nausea (1970); Thrombosis (2100); Vomiting (2144)
Event Date 12/13/2018
Event Type  Death  
Manufacturer Narrative

(b)(4). Concomitant medical products: catalog #: 42502006001, femur cemented cruciate retaining, lot # 64196777, catalog #: 42530006401, natural tibia trabecular metal two-peg, lot # 77007007, catalog #: 42512100412, articular surface medial congruent, lot # 63998720. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the patient has died. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00106, 0001822565-2019-01574, 3007963827-2019-00107, 0002648920-2019-00273. Remains implanted.

 
Event Description

It was reported that the patient underwent an initial left knee on approximately four months ago. The patient died on postop day three due to unknown reason.

 
Manufacturer Narrative

(b)(4). This follow-up report is being submitted to relay additional and/or corrected information. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was further reported that the patient experienced abdominal pain, bloating, nausea, shortness of breath, and vomiting post-operatively day two and morning of day three. Subsequently, the patient expired on post-operative day three due to procedural related complications including deep vein thrombosis (dvt) and possible pulmonary embolism (pe). However, this was unable to be tested due to the patient condition. It was also noted that there were occlusive and non-occlusive thrombus located in the femoral vein as well as non-occlusive thrombus located in other areas.

 
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Brand NamePERSONA ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT
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 Key8523540
MDR Text Key142239122
Report Number3007963827-2019-00107
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42512100412
Device LOT Number63998720
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 Received12/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/08/2018
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: 04/17/2019 Patient Sequence Number: 1
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