MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 3 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz c lm pma catalog #: 154722 lot #: 127210, medical product: oxf twin-peg cmntd fem md pma catalog #: 161469 lot #: 631330, medical product: oxf anat brg lt md size 3 pma catalog #: 159547 lot #: 466820.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00780, 3002806535-2019-00781.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to known reason was performed.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure was performed due to tibial loosening after a fall.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

• Brand Name: OXF ANAT BRG LT MD SIZE 3 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9144432
• MDR Text Key: 167117922
• Report Number: 3002806535-2019-00782
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785933
• UDI-Public: 05019279785933
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: N/A
• Device Catalogue Number: 159547
• Device Lot Number: 466820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention