MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 3 PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Item#154721; lot#6489913; item name# oxf uni tib tray sz b rm pma.Item#166941; lot#j6498247; item name# oxford uni twin-peg femoral sm.G2 ¿ foreign: italy.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent revision surgery due to pain.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided pictures identified a tibial tray, femoral and bearing component which have been explanted.There is what appears to be bone cement attached to the tibial and femoral components.There appears to be some scratching to the tibial and femoral components and possibly on the bearing however the quality of the photos do not allow further assessment.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.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: OXF ANAT BRG RT SM SIZE 3 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: 19971366
• Report Number: 3002806535-2024-00283
• Device Sequence Number: 8923591
• Product Code: NRA
• UDI-Device Identifier: 05019279786145
• UDI-Public: (01)05019279786145(17)240323(10)6496984
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 10/03/2024

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 Expiration Date: 03/23/2024
• Device Model Number: N/A
• Device Catalogue Number: 159568
• Device Lot Number: 6496984
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2019
• 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: 55 YR
• Patient Sex: Unknown