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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: OXF UNI TIB TRAY SZ AA RM PMA
• Common Device Name: 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
• Report Number: 3002806535-2023-00328
• Device Sequence Number: 12485309
• Product Code: NRA
• UDI-Device Identifier: 05019279783144
• UDI-Public: (01)05019279783144(17)300531(10)6764110
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 52 KG