MAUDE Adverse Event Report: BIOMET SPAIN, S.L. VANGUARD PFR FEMORAL LT SM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Arthritis (1723); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date unknown.Implant surgery was (b)(6) 2015.Concomitant medical products: p/n 184784, lot 608490.P/n 00-1112-140-01, lot 80424395.Patient reports allergy (but not confirmed).Ref.(b)(4).Vanguard pfr femoral lt sm was cleared in the u.S.Under 510(k) k000827, fda product code krr.This event was previously reported by the patient under mw5076326.Product remains implanted.

Event Description

It was reported that a patient underwent an initial knee procedure on (b)(6) 2015.It was reported that the patient experienced continuously with pain, swelling and stiffness.

• Brand Name: VANGUARD PFR FEMORAL LT SM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer (Section G): BIOMET SPAIN, S.L.; calle islas baleares, #50; p.o. box 96; fuente del jarro, valencia 46988 ; SP 46988
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7521358
• MDR Text Key: 108484292
• Report Number: 0009610576-2018-00017
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK000827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2018

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: 04/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 11-150908
• Device Lot Number: 2014040696
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2014
• 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): Disability
• Patient Age: 57 YR
• Patient Weight: 77