MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ B RM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: customer has indicated that the product is not available to be returned to zimmer biomet for investigation.Associated products: medical product: oxf anat brg rt sm size 4 pma, catalog #: 159569, lot #: 099510.Medical product:oxf twin-peg cmntd fem sm pma , catalog #: 161468, lot #:915350.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2018.Subsequently, a revision procedure due to tibial loosening was performed on (b)(6) 2021.Attempts have been made but no further information has been provided at this time.

Event Description

It was reported: that patient underwent revision due to tibial loosening.Oxford knee system was implanted on the right knee on (b)(6) 2018 and revised to be replaced with a press-fit knee system on (b)(6) 2021.No further event information available at time of this report.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A review of complaint history was assessed for three years prior to the notification date and identified (3) similar complaints for item#: 154721 (including initiating complaint).There were (0) additional complaints against the lot#: 140280.This device is used for treatment.No compatibility issues were noted.One anteroposterior (ap) radiograph and one mediolateral (ml) radiograph were provided with (b)(4).Date for when the radiographs were taken is not specified.Post-primary radiographs are required in order to assess the initial position, size and alignment of the components.On both provided radiographs, a gap or radiolucent line appears to be present at the interface between the tibial plateau and the tibial tray cement mantle, which suggesting that the implant may have been loose.The provided anteroposterior radiograph shows an uneven distribution of bone cement under the tibial tray, as the layer appears thicker laterally to the keel and below the lateral wall of the tibial tray.The oxford partial knee surgical technique recommends to place a small amount of cement on the tibial bone surface and flatten to produce a thin layer covering the whole under surface.Insert the component and press down, first posteriorly and then anteriorly, to squeeze out excess cement at the front.The fit and positioning of components appear in agreement with the recommendation described in the oxford partial knee surgical technique.The provided mediolateral radiograph shows the presence of debris in front of the anterior edge of the tibial tray, the particles could be fragments of bone cement or bone.Patient is female, was 45 years old at the time of primary surgery, and described as non obese.It was reported that she did not have any other underlying medical conditions.However, a tibial fracture was reported to have occurred during the first revision surgery on (b)(6) 2021, as described in the linked complaint (b)(4), which may be indicative of sub-optimal bone quality.This was confirmed by a medical metrics inc.Report provided with the linked complaint (b)(4), dated 07-sep-2021 and related to the second revision that took place on (b)(6) 2021, where the reviewer noted that bone quality is osteopenic which could contribute to the fracture occurrence.The instructions for use documents included with the oxford tibial tray provided the following information [2]: warnings: 1.Improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.6.Care is to be taken to ensure complete support of all parts of the device embedded in bone cement to reduce risk of stress concentrations, which may lead to failure of the procedure.Complete preclosure cleaning and removal of bone cement debris, metallic debris, and other surgical debris at the implant site is critical to minimize wear of the implant articular surfaces.Implant fracture and loosening due to cement failure has been reported.Possible adverse effects: 10.Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.It is not possible to confirm the exact root cause of the reported tibial tray loosening without examination of the revised components and without provision of relevant surgical notes and additional radiographic and patient information.However, based on the available information, it appears that sub-optimal patient bone quality, and/or sub-optimal cementing technique may have contributed to the reported failure of the device.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.

• Brand Name: OXF UNI TIB TRAY SZ B RM PMA
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• 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: 12427285
• MDR Text Key: 271925082
• Report Number: 3002806535-2021-00380
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388875
• UDI-Public: 05019279388875
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154721
• Device Lot Number: 140280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/06/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female