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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET FINNED PRI STEM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. BIOMET FINNED PRI STEM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Fall (1848)
Event Date 01/18/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: vanguard cr ilok fem-rt catalog # 183006 lot # 6494487, vngd ant stab brg catalog # 189061 lot # 959300, series a pat std catalog # 184764 lot # 069360. 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. Multiple mdr reports were filled for this event: 0001825034-2020-00471, 0001825034-2020-00473, 0001825034-2020-00474. Remains implanted.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient experienced a syncopal episode at home which resulted in a laceration to the nasal bridge of nose.
 
Event Description
From additional information, it was further reported that the patient was prescribed physical therapy approximately one month after surgery for weakness and difficulty with ambulating.
 
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Brand NameBIOMET FINNED PRI STEM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9675820
MDR Text Key177944608
Report Number0001825034-2020-00472
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
PMA/PMN Number
K915132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number141314
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/06/2020 Patient Sequence Number: 1
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