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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS) PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Degraded (1153)
Patient Problem Failure of Implant (1924)
Event Date 02/18/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical products: persona tibia cemented 5 degree stemmed catalog # 42532006402 lot # 64154791; femur cemented posterior stabilized (ps) standard right size 6 catalog # 42500606002 lot # 63740526; all poly patella cemented 32 mm diameter catalog # 42540000032 lot # 54775236; biomet bc r 1x40 us catalog # 110035368 lot # 947baa2510; biomet bc r 1x40 us catalog # 110035368 lot # 947baa2510. The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted. Multiple mdr reports were filled for this event: 3007963827-2021-00059.
 
Event Description
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient was revised due to loosening of the tibial prosthesis with possible pitting of the polyethylene bearing. Attempt for further information has been made, but no further information has been provided.
 
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Brand NamePERSONA ARTICULAR SURFACE FIXED BEARING CONSTRAINED POSTERIOR STABILIZED (CPS)
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 Key11495884
MDR Text Key240346861
Report Number0001822565-2021-00712
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123459
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 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2022
Device Model NumberN/A
Device Catalogue Number42522600510
Device Lot Number63721591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2017
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: 03/16/2021 Patient Sequence Number: 1
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