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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Mechanical Problem (1384)
Patient Problems Muscular Rigidity (1968); Limited Mobility Of The Implanted Joint (2671)
Event Date 11/06/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Associated products : item#:42502006402;femur cemented cruciate retaining (cr) narrow right size 8 lot#:64134763, item#:42532007102;tibia cemented 5 degree stemmed right size e;lot#:64271410, item#:42540000035;all poly patella cemented ;lot#:64422823. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still 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: 3007963827-2020-00003.

 
Event Description

It was reported the patient underwent a manipulation under anesthesia three months after their initial right tka, due to stiffness and limited flexion. It was reported as resolved without further intervention.

 
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Brand NameARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM
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 Key9539504
MDR Text Key173533015
Report Number0001822565-2020-00016
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK150090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522100810
Device LOT Number64348497
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 Received04/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/26/2019
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: 01/02/2020 Patient Sequence Number: 1
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