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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VGXP XP E1 TIB BRG RL 10X71; PROSTHESIS, HIP

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BIOMET ORTHOPEDICS VGXP XP E1 TIB BRG RL 10X71; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Event Date 05/13/2015
Event Type  Injury  
Event Description
It was reported that patient underwent right total knee arthroplasty on (b)(6) 2014.Subsequently, the patient had a resection of scar tissue and arthrotomy performed on (b)(6) 2015.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.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-02344 & 02345).
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Concomitant products: vanguard xp right femoral cat#: 195203 lot: 814150; vanguard xp tibial tray cat#: 195251 lot: 764410; series a patella cat#:184786 lot: 232350; vanguard xp tibial bearing medial cat#: 195403 lot: 820160.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 Name
VGXP XP E1 TIB BRG RL 10X71
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
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 drive
warsaw, IN 46582
5745273773
MDR Report Key4806212
MDR Text Key5915548
Report Number0001825034-2015-02345
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK122160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date05/31/2018
Device Model NumberN/A
Device Catalogue Number195333
Device Lot Number524920
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/13/2015
Initial Date FDA Received05/29/2015
Supplement Dates Manufacturer Received11/29/2017
Supplement Dates FDA Received11/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2013
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
Patient Weight75
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