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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC I-BEAM TRAY PROSTHESIS KNEE

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ZIMMER BIOMET, INC. BIOMET CC I-BEAM TRAY PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Impaired Healing (2378); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: vanguard cr femoral component cat#:183008 lot#: unk, vanguard cr tibial bearing cat#:183444 lot#: unk, vanguard unknown knee patella cat#: unk, lot#: unk. 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. 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. Multiple mdr reports were filed for this event, please see associated reports:0001825034 - 2018 - 06214, 0001825034 - 2018 - 06215, 0001825034 - 2018 - 06216 , 0001825034 - 2018 - 06217. Product remains implanted.

 
Event Description

T was reported that the patient was noted to have open wound away from the incision on unknown date after primary right total knee arthroplasty.

 
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Brand NameBIOMET CC I-BEAM TRAY
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 Key7761503
MDR Text Key116375975
Report Number0001825034-2018-06216
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK142933
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 09/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number141224
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 Received08/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/08/2018 Patient Sequence Number: 1
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