MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 4 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Dislocation (2374)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2 - foreign: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent a uni knee arthroplasty and subsequently there was a dislocation of the mobile inlay during a rotational movement of the left knee joint.Intraoperatively an inlay fracture was detected during replacement surgery.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 and corrected information.D10 - medical devices: oxford uni femoral sm; item# 154600; lot# 2808105 oxf uni tib tray sz b lm pma; item# 154720; lot# 2722794.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

It was reported that the patient underwent an initial left unicompartmental knee arthroplasty.Subsequently, after a twisting movement, the patient experienced pain with an onset of limited range of motion.Revision surgery was performed due to dislocation of the inlay.During the revision, the inlay was found fractured with a defect in the transition from the medial to dorsal underside and continuous on the lateral side.Additionally, the tibial component was slightly medialized.The femoral component remained in place and the tibial and inlay were revised with competitor product.

• Brand Name: OXF ANAT BRG LT SM SIZE 4 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• 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: 18720046
• MDR Text Key: 335534265
• Report Number: 3002806535-2024-00063
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279785872
• UDI-Public: (01)05019279785872(17)170930(10)2829675
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 159541
• Device Lot Number: 2829675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 95 KG