MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL MD; OXFORD CEMENTED FEMORALS

Model Number N/A

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

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 10/11/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a uni knee surgery, and approximately six years later, a revision surgery was performed due to pain and stiffness.The patient experienced ongoing pain and a limited range of motion around 12 months post-op.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10 medical devices: oxf uni tib tray sz c lm pma; item# 154722; lott# 3836115.Oxf anat brg lt md size 4 pma; item# 159548; lot# 3860787.G2 ¿ foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00374.3002806535 - 2023 - 00376.3002806535 - 2023 - 00377.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.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.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.Radiographs were provided and reviewed by a radiologist.The review identified the two views of the left knee demonstrate a medial compartment hemiarthroplasty without hardware failure or loosening.No bony fracture.Overall fit and alignment of the implant is appropriate.Normal bone quality.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: OXFORD UNI TWIN-PEG FEMORAL MD
• Type of Device: OXFORD CEMENTED FEMORALS
• 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: 18082986
• MDR Text Key: 327481316
• Report Number: 3002806535-2023-00376
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00887868354854
• UDI-Public: (01)00887868354854(17)260712(10)J3834742
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 166942
• Device Lot Number: J3834742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 102 KG