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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA CPS VE ART SURFACE PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA CPS VE ART SURFACE PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Pain (1994)
Event Date 05/08/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: the 42532007101, persona stemmed 5-degree tibia, 62753686. The 42500606401, persona ps standard femoral, 62763523. The 00598901215, provisional for stem extension, unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-02996, 0001822565-2018-02995.

 
Event Description

It was reported that patient underwent a revision procedure approximately four years post-implantation due to pain and stiffness. Attempts have been made and additional information on the reported event is unavailable.

 
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Brand NamePERSONA CPS VE ART 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 Key7568551
MDR Text Key110043276
Report Number0001822565-2018-02997
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK123459
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 08/15/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number42512600718
Device LOT Number63389469
OTHER Device ID Number(01) 00889024238114
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/29/2016
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: 06/05/2018 Patient Sequence Number: 1
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