MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB TRAY SZ C LM PMA; KNEE PROSTHESIS

Catalog Number	154722
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Septic loosening (4884)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxf anat brg lt md size 4 pma; item# 159548; lot# 7572308 oxford uni twin-peg femoral md; item# 166942; lot# j7479781.G2 - foreign: new zealand.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
It was reported that approximately one year post initial implantation, the patient underwent a revision surgery due to loosening of the tibial implant.During the procedure, the surgeon also identified a fluid sac, which confirmed the presence of an infection.All components were revised without any reported complications.It has been confirmed that none of the revised implants contributed to the identified infection.Attempts have been made and no further event information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g3, g6, h2, h3, h6, h11.D10 - associated medical device: unknown cement; item # unknown; lot # unknown.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process.Radiographs were provided but not reviewed by a radiologist due to the inability to correlate the image with the allegation.Radiographs were reviewed by r&d department and it appears that the cement mantle is not clearly distinguishable.This can be explained by an insufficient amount of cement implanted, or a problem with the radio-opacity of the cement.Since no additional information was provided on the cement, it is not possible to conclude whether it played a role to the reported event.Additionally, surgeon noticed a sack of fluid when oxford partial knee system was removed, which may indicate a possible infection.This could be a possible contributing factor to the reported implant loosening.Therefore, based on the available information, a definitive root cause could not be determined.The root cause for the reported event of infection is determined to be unrelated to the device.Indeed, during the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.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.

• Brand Name: OXFORD UNI TIB TRAY SZ C LM PMA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22122465
• Report Number: 3002806535-2025-00213
• Device Sequence Number: 12500220
• Product Code: NRA
• UDI-Device Identifier: 05019279388882
• UDI-Public: (01)05019279388882(17)280118(10)6213339
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 08/08/2025

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 Catalogue Number: 154722
• Device Lot Number: 6213339
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown