MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ E RM; PROSTHESIS, KNEE

Catalog Number 166579

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2-foreign- new zealand.D10.Item#: 154927; lot#: 6047141; item name: oxford ph3 cementless fem sz l; item#: 159582; lot#: 6042985; item name: oxf anat brg rt lg size 3 pm.Multiple mdr reports were filed for this event, please see the associated reports: 3002806535 - 2023 - 00446, 3002806535 - 2023 - 00448.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent revision surgery due to pain.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified good bony coverage of the tibial tray.The substrate inside of perimeter rail appears to have significant bone attached to the inferior surfaces and around the keel.Tibial tray appears to have been well fixed to patients tibia.The femur appears to have minimal bone ongrowth.This could be due to patients bone quality e.G.Osteoporotic or similar, however based on the provided photographs this cannot be confirmed as root cause.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Reported event did not occur in an operating room or as part of a medical procedure; therefore, no medical records are available for review.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: OXF UNI CMNTLS TIB SZ E RM
• 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: 18355035
• MDR Text Key: 330876795
• Report Number: 3002806535-2023-00445
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354786
• UDI-Public: (01)00887868354786(17)270725(10)6052528
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 166579
• Device Lot Number: 6052528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2017
• 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): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose