MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB BRG MED SZ4; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 01/29/2024

Event Type  Injury  

Event Description

It was reported that patient underwent a uni knee arthroplasty, and approximately 19 years later a revision surgery was performed due to dislocation of the bearing.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).D10 - medical devices: unknown oxford femoral component; item# unknown; lot# unknown.Unknown oxford tibial component; item# unknown; lot# unknown.G2 - foreign: australia.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

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.Visual examination of provided pictures identified wear marks on the bearing.The batch engraved on the bearing match with the one reported in the complaint.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified a right total knee medial compartment hemi arthroplasty with metal on metal appearance and possible dislodgement of the radiolucent bearing with associated linear marker within the medial aspect of the suprapatellar bursa.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.

• Brand Name: OXFORD UNI TIB BRG MED SZ4
• 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: 18683351
• MDR Text Key: 335069392
• Report Number: 3002806535-2024-00049
• Device Sequence Number: 1
• Product Code: NRA
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2006
• Device Model Number: N/A
• Device Catalogue Number: 154627
• Device Lot Number: S508170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2001
• 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