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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP E1 TIBIAL BEARING LM 12X79 PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS VGXP XP E1 TIBIAL BEARING LM 12X79 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Bearings (734); Pitted (1460); Delamination (2904)
Patient Problems Fall (1848); Unspecified Infection (1930)
Event Date 05/19/2015
Event Type  Injury  
Event Description

It was reported that patient underwent an initial total knee arthroplasty on (b)(6) 2015. Subsequently, patient was revised on (b)(6) 2015 due to deep infection and patient fall shortly after the procedure. During the procedure, it was noted the tibial bearing was pitted and delaminated. The tibial bearings were removed and replaced.

 
Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 2 states, "early or late postoperative infection and/or allergic reaction. " under warnings states, "accepted practices in postoperative care are important. Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure. The patient is to be advised of the limitations of the reconstruction, and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred. " device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results. Review of sterilization certification confirms device was sterilized in accordance with iso 11137-2. This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-02618 / 02619).

 
Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance. Evaluation of returned device found no signs of pitting or delamination on the bearing, as there had been no removal of material in the bearing. Rather, the damage is likely deformation due to third-party debris. The complaint is confirmed, but for reasons of third-party debris, not for pitting or delamination.

 
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Brand NameVGXP XP E1 TIBIAL BEARING LM 12X79
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key4848782
MDR Text Key21546724
Report Number0001825034-2015-02618
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK132873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date06/23/2019
Device MODEL NumberN/A
Device Catalogue Number195894
Device LOT Number613860
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/02/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/25/2014
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: 06/16/2015 Patient Sequence Number: 1
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