MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 3 PMA; IMPLANT, KNEE

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	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Oxford ph3 cementless fem sz l pc/ha item# 154927, lot# 7495480.Oxf uni cmntls tib sz e rm item# 166579, lot# 7480195.G2.Report source: australia.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 the patient underwent an initial knee surgery and subsequently, 5 months post implantation, was revised due to pain in the lateral compartment.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned but some pictures were provided; due to the low quality of the pictures a further analysis is not possible.A review of the device manufacturing records confirmed no abnormalities or deviations.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.Complaints are monitored per complaint trending process.Medical records were provided and reviewed by a health care professional.Radiographs were provided and reviewed by a radiologist.A medial unicompartmental arthroplasty is present in the right knee.The implant shows no signs of loosening or fracture, and its fit remains stable.A minimal varus deformity of the knee is observed, but it is unlikely to necessitate revision.Bone quality appears mildly osteopenic.There is no evidence of abnormal radiolucency or other abnormalities.The lateral compartment of the knee appears normal, with no significant findings apart from the minimal varus deformity.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: OXF ANAT BRG RT LG SIZE 3 PMA
• Common Device Name: IMPLANT, KNEE
• 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: 20472239
• Report Number: 3002806535-2024-00398
• Device Sequence Number: 7471767
• Product Code: JWH
• UDI-Device Identifier: 05019279786282
• UDI-Public: (01)05019279786282(17)290123(10)7703977
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/19/2024

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 Model Number: N/A
• Device Catalogue Number: 159582
• Device Lot Number: 7703977
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male