MAUDE Adverse Event Report: BIOMET UK LTD UNKNOWN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Information was received based on review of a journal article entitled, "minimally invasive oxford phase 3 unicompartmental knee replacement." this prospective study describes the outcome of the first 1000 phase 3 oxford medial unicompartmental knee replacements implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently.A patient was identified in the article that underwent partial knee arthroplasty on an unknown side on an unknown date.Patient follow-up results provided at 0.43 year post-implantation indicates patient underwent a revision surgery on an unknown date due to infection.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).The article was written by h pandit in bone joint surg (br} 2011;93-8:198¿204.This information was originally reported on 1825034-2015-02246 which referenced a journal article written on a study that this patient took part in.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.Product location unknown.

Event Description

Information was received based on review of a journal article entitled, "minimally invasive oxford phase 3 unicompartmental knee replacement." this prospective study describes the outcome of the first 1000 phase 3 oxford medial unicompartmental knee replacements implanted using a minimally invasive surgical approach for the recommended indications by two surgeons and followed up independently.A patient was identified in the article that underwent partial knee arthroplasty on an unknown side on an unknown date.Patient underwent a revision procedure 0.43 years post-implantation due to infection.During the procedure, all components were removed, and patient underwent a two stage revision to a total knee.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN KNEE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterlon industrial estate; bridgend, south wales
• 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: 4799638
• MDR Text Key: 18089977
• Report Number: 0001825034-2015-02249
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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