MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD ANAT BRG LT X-SM SZ 3 PMA; KNEE PROSTHESIS

Catalog Number	159790
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: oxf ph3 cementless fem sz xsm; item# 154912; lot# 6770352 oxf uni tib tray sza lm; item# 154718; lot# 6764071 g2 - foreign: japan 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 approximately three years and seven months post initial implantation, the patient underwent a left sided knee revision due to joint instability.The surgeon suspects bearing wear as the cause.Due diligence is in progress for this complaint; no further additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h11.Visual examination of the returned product identified signs of use (nicks, gouges) and appears to have wear.Dimensional analysis results were within specification.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 found no additional related complaints for this item and the reported part and lot combination.Based on the available information, the reported event can be confirmed.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.

• Brand Name: OXFORD ANAT BRG LT X-SM SZ 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: 19350808
• Report Number: 3002806535-2024-00181
• Device Sequence Number: 17962221
• Product Code: NRA
• UDI-Device Identifier: 05019279068937
• UDI-Public: (01)05019279068937(17)250323(10)6769978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/28/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/23/2025
• Device Catalogue Number: 159790
• Device Lot Number: 6769978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown