MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB TRAY SZ D LM PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left knee procedure approximately seven years ago.Subsequently, the patient has stated the knee goes out and the patient drops to the ground.It happens randomly while patient is walking around.According to the patient, the failure stared last year.The patient visited his surgeon, x-rays were taken and the surgeon reported that nothing looked out of place.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 - oxf anat brg lt md size 5 pma, item# 159549, lot# 374050.Oxf twin-peg cmntd fem md pma, item# 161469, lot# 738080.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).This follow-up report is being submitted to relay additional information.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.With the available information, a definitive root cause could not 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: OXFORD UNI TIB TRAY SZ D LM PMA
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL
• 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: 19104016
• Report Number: 3002806535-2024-00141
• Device Sequence Number: 7268197
• Product Code: NRA
• UDI-Device Identifier: 05019279388905
• UDI-Public: (01)05019279388905(17)261201(10)184890
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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 Model Number: N/A
• Device Catalogue Number: 154724
• Device Lot Number: 184890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2016
• 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 H11 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male