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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY PROSTHESIS KNEE

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ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 02/27/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Vanguard as tibial bearing, catalog # ep-189080, lot # 835850, vanguard cr femoral, catalog # 183030, lot # 231010, biomet modular tibial locking bar, catalog # 141205, lot # 759920; cobalt g-hv bone cement 40g, catalog # 402283, lot # 232350, cobalt g-hv bone cement 40g, catalog # 402283, lot # 156410. The complaint device has been returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch will be submitted. Multiple mdr reports were filled for this event: 0001825034-2019-03030, 0001825034-2019-03034, 0001825034 - 2019 - 03033.

 
Event Description

It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient underwent a manipulation procedure due to stiffness approximately one year post-implantation. The patient underwent a revision procedure approximately one year later. During the revision procedure, the surgeon noted the tibia was essentially loose and easily removed. The implant had failed at the cement implant interface. All the implants were removed and replaced with competitor product.

 
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Brand NameBIOMET CC CRUCIATE 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 Key8812541
MDR Text Key151755195
Report Number0001825034-2019-03136
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK171054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number141234
Device LOT NumberJ3465523
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/13/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/10/2014
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: 07/22/2019 Patient Sequence Number: 1
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