MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 7 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED

Model Number	N/A
Medical Device Problem Codes	Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 4 months post-op, the patient underwent revision surgery as the tibial tray had not osseointegrated into the bone, and was loose.Patient was revised to a cemented tibial tray, and the bearing was exchanged.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).D10: oxf uni tib tray sza rm; item#: 154719; lot#: 7265282.G2- new zealand.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00320.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.
Additional Manufacturer Narrative
(b)(4).Upon review of this complaint from an investigation perspective, it is considered that the oxf anat brg rt md size 7 pma, within this complaint, does not impact the reported event.The device involved in the reported event has already been reported.See report number 3002806535 - 2023 - 00321.Given the above information, this product will now be considered an associated item.
Event or Problem Description
Upon review of this complaint from an investigation perspective, it is considered that the oxf anat brg rt md size 7 pma, within this complaint, does not impact the reported event.The device involved in the reported event has already been reported.See report number 3002806535 - 2023 - 00321.

• Brand Name: OXF ANAT BRG RT MD SIZE 7 PMA
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED
• 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: 17823400
• Report Number: 3002806535-2023-00321
• Device Sequence Number: 6206030
• Product Code: NRA
• UDI-Device Identifier: 05019279786251
• UDI-Public: (01)05019279786251
• 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: 2023
• 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): 10/09/2023

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: 159579
• Device Lot Number: UNKNOWN
• 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: 10/06/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose