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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VG 360 OTI TIB SLV SM HALF B PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. VG 360 OTI TIB SLV SM HALF B PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 148291 - bmt splined knee stm v2 16x40 ¿ 999910; 141355 - rgx 3 peg ser a patella 28mm ¿ 528570; 148301 - bmt splined knee stm v2 11x80 ¿ 739010; 183808 - vngd ssk psc tib brg sm 18x59 ¿ 546740; cp116182 - ti p aug 57. 5 rt 360 fmrl ¿ 117060; cp116184 - cus ti por 59 360 tib tray ¿ 117070; 185212 - bmt 360 7. 5mm offset adapter - 947060. 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: 0001825034 - 2019 - 02013; 0001825034 - 2019 - 02014; 0001825034 - 2019 - 02015; 0001825034 - 2019 - 02016; 0001825034 - 2019 - 02018; 0001825034 - 2019 - 02019.

 
Event Description

It was reported that the patient began experiencing pain, burning, and difficulty ambulating approximately 3 years after knee revision surgery.

 
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Brand NameVG 360 OTI TIB SLV SM HALF B
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 Key8573231
MDR Text Key143822821
Report Number0001825034-2019-02017
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK140883
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 01/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number185536
Device LOT Number602200
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 Received01/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/24/2015
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: 05/02/2019 Patient Sequence Number: 1
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