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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR RIGHT SIZE 6 PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. PERSONA FEMUR RIGHT SIZE 6 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Pain (1994)
Event Date 08/06/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the hospital will not permit it. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 42532007502 lot # 63092882, item # 42540000035 lot # 62766582, item # 42521200513 lot # 62773644. Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00618, 0002648920-2019-00619, 0002648920-2019-00620.

 
Event Description

It was reported that a patient underwent an initial knee procedure on unknown date. Subsequently, the patient was revised due to pain & loosening.

 
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Brand NamePERSONA FEMUR RIGHT SIZE 6
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 Key8920049
MDR Text Key155171866
Report Number0001822565-2019-03530
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42502606002
Device LOT Number62795685
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 Received01/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/23/2014
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: 08/22/2019 Patient Sequence Number: 1
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