MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI FEMORAL SM; 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
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: oxf anat brg rt sm size 5 pma item#159570 lot#3032998.Oxf uni tib tray sz c rm pma item#154723 lot#3922418.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00017-1.The femoral component remains implanted and therefore not returned so visual and dimensional evaluations could not be performed.A review of the device manufacturing records for the femoral component confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided and reviewed by a 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
It was reported that patient underwent right knee revision surgery due to luxation, approximately five (5) years and nine (9) months from initial implantation.Attempts have been made and no further information has been provided.

• Brand Name: OXFORD UNI FEMORAL SM
• 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: 16722472
• Report Number: 3002806535-2023-00091
• Device Sequence Number: 12750055
• Product Code: NRA
• UDI-Device Identifier: 05019279001248
• UDI-Public: (01)05019279001248(17)260917(10)J3877349
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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: 09/17/2026
• Device Model Number: N/A
• Device Catalogue Number: 154600
• Device Lot Number: J3877349
• 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: 03/24/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2016
• 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
• 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 Age: 71 YR
• Patient Sex: Male