MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING LEFT MEDIAL 4MM THICK; PROSTHESIS, KNEE

Catalog Number 159555

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374); No Code Available (3191)

Event Date 02/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: oxford femur catalog 161470 lot 221570; oxford tibial tray catalog 154722 lot 566600.The information provided on this form was previously submitted under manufacturing report number 0001825034-2017-02306-1.

Event Description

It was reported that the patient underwent a left knee revision procedure approximately six weeks post implantation due to dislocation of the tibial bearing, which also led to pain, instability, and stiffness.The tibial and femoral components were intraoperatively noted to have no loosening.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient underwent a left knee revision procedure approximately six weeks post implantation due to dislocation of the tibial bearing, which also led to pain, instability, and stiffness.The tibial and femoral components were intraoperatively noted to have no loosening.It was further reported that the bearing dislocation was caused by patient ligament laxity.No additional patient consequences were reported.

Manufacturer Narrative

Report reference no: mw5074262.Reported event was confirmed by review of x-rays provided.Device history record (dhr) was reviewed and no discrepancies were found.The hospital reported that the patient previously had an acl reconstruction.The surgeon stated that ¿it was the patient¿s soft tissue that loosened causing the bearing to dislocate.Neither the tibial or femoral components loosened.¿ a review of the ifu and the surgical technique found that one of the contraindications for the oxford partial knee surgery states "insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device.¿ from information supplied by the hospital in regards to reported complaint and the investigation performed by biomet (b)(4) ltd, the most likely cause of the reported bearing dislocation was due to soft tissue loosening.

• Brand Name: OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING LEFT MEDIAL 4MM THICK
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): .; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6542016
• MDR Text Key: 74355636
• Report Number: 3002806535-2017-00270
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/23/2020
• Device Catalogue Number: 159555
• Device Lot Number: 271970
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 146