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

Catalog Number 154601

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 06/18/2014

Event Type  Injury  

Manufacturer Narrative

Udi# - (b)(4).Concomitant product(s): - oxford right anatomical bearing, catalog 159577, lot 558939; oxford tibial tray, catalog 154725, lot 535538.Contact office: - (b)(4).Customer has not indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a knee revision procedure approximately 11 years post implantation due to femoral loosening.The patient was converted from a partial to a total knee prosthesis.No additional patient consequences were reported.

• 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: 6411162
• MDR Text Key: 70171817
• Report Number: 3002806535-2017-00146
• 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: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 154601
• Device Lot Number: 631567
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2003
• 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