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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PS VE ARTICULAR SURFACE PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA PS VE ARTICULAR SURFACE PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 03/11/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical products: persona all poly patella catalog # 42540000032 lot # 62445364. Persona ps narrow femoral catalog # 42500006401 lot # 62369093. Persona stemmed 5-degree tibia catalog # 42532007101 lot # 62424063. Persona ps ve articular surface catalog # 42512400710 lot # 62409274. Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted. Multiple mdr reports were filled for this event: 0002648920-2020-00286. 3007963827-2020-00147. 0002648920-2020-00288.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was experiencing pain and difficulty in range of motion. The patient underwent a manipulation under anesthesia with cortisone injection due to arthrofibrosis.
 
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Brand NamePERSONA PS VE ARTICULAR SURFACE
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 Key10112332
MDR Text Key195246646
Report Number0001822565-2020-01954
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 consumer,distributor,health p
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2018
Device Model NumberN/A
Device Catalogue Number42512400710
Device Lot Number62409274
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 Received06/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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