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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 13 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 13 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Impaired Healing (2378); Patient Problem/Medical Problem (2688)
Event Date 08/10/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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: (b)(4). 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: 3007963827-2020-00228, 3007963827-2020-00229, 0002648920-2020-00421.

 
Event Description

It was reported that a patient underwent a primary unilateral total knee. Approximately three weeks post implantation, the patient was noted to have delayed wound healing requiring medical intervention.

 
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Brand NameARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 13 MM HEIGHT
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 Key10552880
MDR Text Key207503628
Report Number0001822565-2020-03274
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 09/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42522100813
Device LOT Number64557921
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 Received09/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/06/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/18/2020 Patient Sequence Number: 1
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