MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 5 PMA; KNEE PROTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent right knee revision surgery due to luxation, approximately five (5) years and nine (9) months from initial implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Report source foreign: germany.Concomitant medical products: oxford uni femoral sm item#154600 lot#j3877349; oxf uni tib tray sz c rm pma item#154723 lot#3922418.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).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, h10.Visual examination of the returned product identified slight wear and discolouration on the top articulating radius consistent with being implanted for more than 5 years, otherwise the bearing appears to be in good condition.A review of the device manufacturing records confirmed no abnormalities or deviations.Device used for treatment.Radiographs were provided and reviewed from an radiologist: significant findings include subluxation of the femoral component as well as displaced polyethylene lining on the later time point.The original time points demonstrate possible improper sizing of the hardware for the bones.With the available information, a definitive root cause cannot 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 5 PMA
• Common Device Name: KNEE PROTHESIS
• 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: 16181905
• Report Number: 3002806535-2023-00017
• Device Sequence Number: 19440379
• Product Code: NRA
• UDI-Device Identifier: 05019279786169
• UDI-Public: (01)05019279786169(17)180430(10)3032998
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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): 04/03/2023

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: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 159570
• Device Lot Number: 3032998
• 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: 12/30/2022
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2016
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male