MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial partial knee arthroplasty and approximately 5 years later a revision surgery was performed due to unknown reason.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10- oxf twin-peg cmntd fem lg pma, item161470, lot# 016890.Oxf anat brg rt lg size 3 pma item#159582, lot#385560.Biomet bone cement r 1x40 us item# 110035368, lot# 745aah1407.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00197, 3002806535-2023-00198.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
Upon reassessment of the reported event, it was determined to be a duplicate of mfr report number 3002806535-2023-00194.Hence this report should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be a duplicate of mfr report number 3002806535-2023-00194.Hence this report should be voided.

• Brand Name: OXF UNI TIB TRAY SZ D RM PMA
• Common Device Name: KNEE PROSTHESIS
• 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: 17246875
• Report Number: 3002806535-2023-00200
• Device Sequence Number: 15161230
• Product Code: NRA
• UDI-Device Identifier: 05019279388912
• UDI-Public: (01)05019279388912(17)280628(10)999960
• 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: 2018
• 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): 08/01/2023

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: 154725
• Device Lot Number: 999960
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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: Male