MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE MEDIUM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implanted on an unknown date in 2003.Concomitant products: oxford medium meniscal bearing, catalog 154626, lot s596846; oxford right medial tibial tray 53x34 mm, catalog 154616, lot s535713.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 be bearing.Without further information an root cause cannot be determined.This report is number 2 of 3 mdrs filed for the same event (reference 3002806535-2016-00863 / 3002806535-2017-00083 / 3002806535-2017-00084).

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.

• Brand Name: OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SIZE MEDIUM
• 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: 6354666
• MDR Text Key: 68209221
• Report Number: 3002806535-2017-00083
• 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: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 154601
• Device Lot Number: S643472
• 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: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2003
• 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