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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD CR TIB BRG 12X63/67 PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VNGD CR TIB BRG 12X63/67 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 05/01/2006
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint number (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it remains implanted. The investigation is in process and once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated report(s): 0001825034 - 2018 - 06955; 0001825034 - 2018 - 06972; 0001825034 - 2018 - 06976; 0001825034 - 2018 - 06988. Remains implanted.
 
Event Description
It was reported a patient underwent primary left total knee arthroplasty two months post-implantation. Subsequently the patient experienced a fall and suffers a fracture. No additional patient consequences were reported.
 
Manufacturer Narrative
(b)(4). The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed. Device history record was not reviewed due to item and lot identification is necessary for review. The root cause was unable to be determined as cause of fall is unknown. 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.
 
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Brand NameVNGD CR TIB BRG 12X63/67
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 Key7763394
MDR Text Key116452501
Report Number0001825034-2018-06972
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK171054
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 10/09/2018
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
Device Model NumberN/A
Device Catalogue Number183422
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 Received09/11/2018
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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