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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Information was received based on review of a journal article titled, "lateral unicompartmental arthroplasty with the oxford meniscal knee" which reports the results of 53 knees with lateral compartmental osteoarthritis treated by unicompartmental arthroplasty with the oxford meniscal knee manufactured at biomet.A patient was identified in the article that underwent partial knee arthroplasty on an unknown date.Patient follow-up results provided at month 11 post-implantation indicates patient underwent a revision surgery on an unknown date due to bearing dislocation.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.The following sections could not be completed with the limited information provided.Date of event - unknown.Expiration date/lot number - unknown.Date implanted - unknown.Date explanted - unknown.Initial reporter - the article was written by t.V.Gunther in the knee 3 (1996) 33-39.Pma/510(k) number ¿ unknown.Manufacture date ¿ unknown.This information was originally reported on 1825034-2015-02227, which referenced a journal article written on a study that this patient took part in.

• Brand Name: UNKNOWN KNEE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterlong industrial estateq; bridgend, southe wales CF31 3XA; UK CF31 3XA
• 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: 4799520
• MDR Text Key: 5917432
• Report Number: 0001825034-2015-02231
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2015

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?: Yes
• Date Manufacturer Received: 04/29/2015
• 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
• Patient Age: 82 YR