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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); No Information (3190)

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.

• 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 Key: 4806212
• MDR Text Key: 5915548
• Report Number: 0001825034-2015-02345
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122160
• Number of Events Reported: 1
• 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 Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 195333
• Device Lot Number: 524920
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 05/29/2015
• Supplement Dates Manufacturer Received: 11/29/2017
• Supplement Dates FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 75