MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD BEARING; KNEE PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)

Event Date 09/04/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.H3 other text : product is unknown.

Event Description

It was reported that the patient underwent an initial right unicompartmental knee arthroplasty.Approximately 10 years later a revision surgery was performed due to knee locking with impingement, pain, and swelling.During the revision noted the polyethylene snapped in half.The polyethylene was exchanged.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided pictures confirmed a fractured bearing component.There also appears to be some missing material along the visible edge and corner of the bearing.Nothing further can be gained from the pictures.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Radiographs were provided and reviewed by a radiologist who reported that malrotation of the femoral component is present and the tibial component is intact.There is chondrocalcinosis of the lateral meniscus and no acute fracture.With the available information, a definitive root cause cannot 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: UNK OXFORD BEARING
• Type of Device: KNEE PROSTHESIS
• 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: 17841882
• MDR Text Key: 324548625
• Report Number: 3002806535-2023-00323
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNK OXFORD BEARING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male