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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA STEMMED TIBIA PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA STEMMED TIBIA PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Embolism (1829); Cancer (3262)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical product: persona femur cemented posterior stabilized (ps) standard catalog # 42500606402 lot # 63362725, persona articular surface fixed bearing posterior stabilized (ps) catalog # 42522400713 lot # 63029895, persona all poly patella catalog # 42540200035 lot # 63326893, 3. 5mm hex head screw x38mm catalog # 20800000018 lot # unknown. The complainant 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. Event was initially reported on 0001822565-2019-04978. Multiple mdr reports were filled for this event: 3007963827-2020-00040, 0001822565-2019-04979, 0001822565-2019-05075. Remains implanted.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was experienced a blood clot from the surgery. Attempt for further information has been made, but no further information has been provided.
 
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Brand NamePERSONA STEMMED TIBIA
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 Key9643265
MDR Text Key177538538
Report Number3007963827-2020-00039
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number42532007102
Device Lot Number63315961
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 Received04/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2016
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: 01/29/2020 Patient Sequence Number: 1
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