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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Material Rupture (1546)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Rupture (2208)

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 2.12 year post-implantation indicates patient underwent a revision surgery on an unknown date due to pain and swelling, traumatic acl rupture, loose tibial component and subsequent infection after acl reconstruction.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).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.

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.Subsequently, patient underwent a acl reconstruction surgery on an unknown date due traumatic acl rupture.Following the acl reconstruction, the patient was revised due to infection 2.12 years after primary procedure.Upon opening it was noted that the tibial component was loose and there was destruction of the lateral compartment.All components were removed.Patient underwent two stage conversion to a total knee.

• 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: 4799668
• MDR Text Key: 5881821
• Report Number: 0001825034-2015-02260
• 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: Literature,literature
• 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

• 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
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• 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