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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 67MM PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 67MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Loss of Range of Motion (2032); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Additional product: vanguard femoral component pn 183122, vanguard tibial bearing pn ep-183620, series a patella pn 184784, cobalt hv bone cement 40g pn 402282. Customer has not indicated that the product will be returned to zimmer biomet for investigation as it 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: 0001825034-2019-04585, 0001825034-2019-04593, 0001825034-2019-04596.

 
Event Description

Patient reported experiencing swelling, limited range of motion, instability and loosening approximately two years post left knee arthroplasty. Patient is unsure if it is the joint that is loose or the devices. Surgeon is suggesting devices be replaced. No revision has been reported.

 
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Brand NameBIOMET CC CRUCIATE TRAY 67MM
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 Key9233588
MDR Text Key163719632
Report Number0001825034-2019-04598
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 CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number141232
Device LOT NumberJ6069127
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 Received02/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/17/2017
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: 10/24/2019 Patient Sequence Number: 1
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