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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA STEMMED RIGHT PROSTHESIS KNEE

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ZIMMER BIOMET, INC. PERSONA TIBIA STEMMED RIGHT PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problems Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: unknown-femoral unknown-bearings. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted. 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: 0001822565-2018-04561, 0001822565-2018-04562. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.

 
Event Description

It was reported that the patient underwent knee arthroplasty; subsequently the patient is experiencing pain, swelling, limited mobility, and loosening.

 
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Brand NamePERSONA TIBIA STEMMED RIGHT
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 Key7808328
MDR Text Key117959712
Report Number0001822565-2018-04560
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 CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42532006402
Device LOT Number63553334
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 Received07/03/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/23/2016
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: 08/23/2018 Patient Sequence Number: 1
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