MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; PROSTHESIS, KNEE

Catalog Number 159576

Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product ¿ unknown large oxford femur; unknown oxford tibia.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a knee revision procedure approximately one year post implantation due to dislocation of the tibial bearing.It was noted that a medium size tibial bearing had initially been used with a large size femur; the tibial bearing was removed and replaced with a large bearing.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA
• 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: 6471902
• MDR Text Key: 72110725
• Report Number: 3002806535-2017-00205
• 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: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/26/2020
• Device Catalogue Number: 159576
• Device Lot Number: 3669067
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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: 67 YR