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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Pain (1994)
Event Date 08/26/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical product: persona tibia cemented stemmed catalog # 42532006402 lot # 62680695; persona femur cemented posterior stabilized (ps) catalog # 42500005802 lot # 62417581; persona ve all poly patella catalog # 42540200029 lot # 62726872; 2. 5 mm female hex screw 25 mm length catalog # 42509902525 lot # 62417031; headless trocar drill pin 3. 2 mm diameter 75 mm length catalog # 00590102000 lot # 62566004. Customer has indicated that the product will not be returned because requested but not returned by hospital. Once the investigation  has been completed, a follow-up mdr will be submitted.   multiple mdr reports were filled for this event: 0001822565-2020-03180. Not returned by hospital.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient had fall and was revised due to tibial pain. 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 BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10534634
MDR Text Key207114618
Report Number0001822565-2020-03179
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121771
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 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Model NumberN/A
Device Catalogue Number42522400412
Device Lot Number62384597
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 Received10/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 09/15/2020 Patient Sequence Number: 1
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