MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ F LM PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED

Catalog Number	154775
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Insufficient Information (4580)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10.Item#: 161470; lot#:65677737; item name: oxf twin-peg cmntd fem lg pma; item#: 159554; lot#: 65677138; item name: oxf anat brg lt lg size 3 pma; item#: 98-b002-006-01; lot#:unknown; item name:oxf uni fm/cm tb/uni.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00281, 3002806535 - 2023 - 00282.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).Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford tibial component within this complaint has not caused or contributed to the reported event.Given the above information this medwatch will be voided.
Event or Problem Description
Additional information was received indicating that a revision surgery was needed due to lateral progression of the patient's arthritis.Upon review of this information, it is now considered that the oxford tibial component within this complaint has not caused or contributed to the reported event.Hence this report will be voided.

• Brand Name: OXF UNI TIB TRAY SZ F LM 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: 17583620
• Report Number: 3002806535-2023-00283
• Device Sequence Number: 20095028
• Product Code: NRA
• UDI-Device Identifier: 05019279389155
• UDI-Public: (01)05019279389155(17)320726(10)591490
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 154775
• Device Lot Number: 591490
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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 Age: 76 YR
• Patient Sex: Male