MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNICOMPARTMENTAL KNEE PHASE 3 MENISCAL BEARING MEDIUM 3MM THICK; PROSTHESIS, KNEE

Model Number N/A

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 10/31/2016

Event Type  Injury  

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.Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.

Event Description

Patient underwent a revision of a partial knee to a total knee due to mechanical failure approximately 13 years post implantation.The bearing was fractured and showed signs of impingement and both femoral and tibial components were loose and reportedly appeared undersized in preoperative x-rays.

Manufacturer Narrative

(b)(4).Concomitant products: oxford size medium femoral: catalog 154601, lot s643472.Oxford right medial tibial tray 53x34 mm: catalog 154616, lot s535713.(b)(4).Visual inspection of the bearing also showed pitting and wear across the entire articulating surface and confirms the implant fracture.Evidence of loosening is clearly visible on the femoral component where burnishing and polishing is present on the cement surface.The tibial component appeared smooth but there was no evidence of burnishing.The smooth appearance of the cement may indicate that it had over cured prior to seating the components, however, this cannot be confirmed with the information provided.The loosening of the components could have occurred as a result of the bearing fracture and impingement or could have contributed to the fracture of the bearing.Without further information an root cause cannot be determined.This report is number 1 of 3 mdrs filed for the same event (reference 3002806535-2016-00863 / 3002806535-2017-00083 / 3002806535-2017-00084).

• Brand Name: OXFORD UNICOMPARTMENTAL KNEE PHASE 3 MENISCAL BEARING MEDIUM 3MM THICK
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6136392
• MDR Text Key: 61157191
• Report Number: 3002806535-2016-00863
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2008
• Device Model Number: N/A
• Device Catalogue Number: 154626
• Device Lot Number: S596846
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2003
• 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