MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 6 PMA; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL

Model Number	N/A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from a clinical study that a patient had an initial right medial knee unicondylar arthroplasty approximately one year ago.A month ago the patient was converted to a total knee arthroplasty due to persistent pain and malalignment.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D-10 oxf uni cmntls tib sz c rm, item# 166575, lot# 7246480.Oxford ph3 cementless fem sz m, item# 154926, lot# 7349086.G2 ¿ foreign ¿ netherlands.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2024 - 00092, 3002806535 - 2024 - 00093.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
The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the complaint histories identified additional similar complaints for the item ref.(b)(4), no additional related complaints for items ref.(b)(4), and no additional similar complaints for the reported part and lot combinations.Medical records were provided and reviewed by a health care professional.The review of the initial notes identified an uncemented initial medial knee hemiarthroplasty without complications.Review of the revision notes identified a revision due to malalignment and persistent pain, without complication.No contributing factors to the event were found.Radiographs were provided and reviewed by a radiologist.The review of the immediate post-op images demonstrates anatomic alignment of a medial unicompartmental arthroplasty without abnormality.An interval change in position of the tibial implant which appears slightly rotated and subsided was identified.A lateral view would be of value for better characterization of the implant position.There is no fracture.Finally, a review of the x-ray in the standing position, revealed the tibial implant appearing again malpositioned but unchanged.There is pelvic obliquity higher on the left.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: OXF ANAT BRG RT MD SIZE 6 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: 18920195
• Report Number: 3002806535-2024-00094
• Device Sequence Number: 6247969
• Product Code: NRA
• UDI-Device Identifier: 05019279786244
• UDI-Public: (01)05019279786244(17)260617(10)7052368
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: 06/17/2026
• Device Model Number: N/A
• Device Catalogue Number: 159578
• Device Lot Number: 7052368
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 105 KG