MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VANGUARD M UNI FMRL MED; PROSTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the 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 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-02353 and 3002806535-2016-00396.

Event Description

Information was received based on review of a journal article titled, "multi-center study of 825 phase iii oxford medial compartmental arthroplasty knees: an average ten-year survival analysis in the united states." which aimed to examine the first long-term survivorship with a large patient sample size study in the united states looking at various aspects of the phase iii oxford design while also addressing recent advancements that can help aid the uka process and improve partial knee survivorship.A patient was identified that underwent a right partial knee arthroplasty.Patient follow-up results provided at 7 years post-implantation indicates the patient underwent a revision procedure due to dislocation.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to not be reportable, event will be reported on 3002806535-2016-00396.

• Brand Name: VANGUARD M UNI FMRL MED
• Type of Device: PROSTHESIS, 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 Key: 5758749
• MDR Text Key: 48444213
• Report Number: 0001825034-2016-02353
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2015
• Device Model Number: N/A
• Device Catalogue Number: US154601
• Device Lot Number: 705170
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2005
• 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: 54 YR
• Patient Weight: 91