MAUDE Adverse Event Report: . OXF UNI TIB TRAY SZ AA RM PMA; OXFORD CEMENTED TIBIAL TRAY

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices: oxford uni twin-peg femoral xs; item#: 166940; lot#: j6383015.Oxf anat brg rt x-sm 6mm pma; item# :160793; lot#: 7052325.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

It was reported that the patient underwent an initial knee arthroplasty and approximately 2 years later a revision surgery was performed due to the subsidence of the tibial component.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.The following sections were updated: a2, a4, b4, b5, b7, g3, g6, h1, h2, h3, h6, h10.No product was 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.Device is used for treatment.Medical records were provided and reviewed by a health care professional.There is a medial unicompartmental arthroplasty of the right knee.There is tibial implant loosening and subsidence greatest posteriorly and medially with mild knee varus alignment.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.

Event Description

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

• Brand Name: OXF UNI TIB TRAY SZ AA RM PMA
• Type of Device: OXFORD CEMENTED TIBIAL TRAY
• Manufacturer (Section D): .; 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: 17850206
• MDR Text Key: 324660992
• Report Number: 3002806535-2023-00328
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279783144
• UDI-Public: (01)05019279783144(17)300531(10)6764110
• 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: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 159532
• Device Lot Number: 6764110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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: Prefer Not To Disclose
• Patient Weight: 52 KG