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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. AGC DA 2000 TIBIAL TRAY 75MM UNCOATED KNEE TIBIA PROSTHESIS, METALLIC

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BIOMET UK LTD. AGC DA 2000 TIBIAL TRAY 75MM UNCOATED KNEE TIBIA PROSTHESIS, METALLIC Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 08/27/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial report. Report source, foreign - event occurred in (b)(6). (b)(6). (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded. Concomitant medical devices: medical product: unknown fem stem, catalog #: unknown, lot #: unknown; medical product: agc da 2000 femoral right 60mm, catalog #: 154806, lot #: 1676815; medical product: unknown biomet stem tib, catalog #: unknown, lot #: unknown; medical product: agc da2000 kn tib brg 71/75x12, catalog #: 154840, lot #: 1572860. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00422, 3002806535-2020-00423, 3002806535-2020-00424, 3002806535-2020-00425. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. The product has been discarded.

 
Event Description

It was reported that the vanguard da revised due to aseptic loosening. It was also reported that the aseptic loosening is not due to the implant failure; therefore, the implants have been discarded. Surgeon confirmed verbally on the (b)(6) 2020 that no additional information available. X-rays have been provided by the hospital and they are in the process to be reviewed by our research department.

 
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Brand NameAGC DA 2000 TIBIAL TRAY 75MM
Type of DeviceUNCOATED KNEE TIBIA PROSTHESIS, METALLIC
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10565413
MDR Text Key207892523
Report Number3002806535-2020-00421
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number154814
Device LOT Number2560652
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 Received09/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/23/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 09/22/2020 Patient Sequence Number: 1
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