MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C RM PMA; KNEE PROSTHESIS

Model Number 154723

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 03/28/2023

Event Type  Injury  

Event Description

It was reported that approximately six (6) years after the initial surgery, a patient underwent a right sided unicompartmental knee arthroplasty to total knee arthroplasty conversion for unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - medical devices: oxf anat brg rt md size 3 pma; item# 159575; lot# 942780.Oxf twin-peg cmntd fem md pma; item# 161469; lot# 120790.Multiple mdr reports were filed for this event: 3002806535-2023-00122; 3002806535-2023-00123.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 Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No products were returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing record confirmed no abnormalities or deviations.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.Significant findings include that the unicompartmental knee arthroplasty, involving the medial compartment of the right knee, appears anatomically aligned without periprosthetic lucencies.A threaded screw is noted extending from the level between the tibial spines inferolaterally to closely approximate the lateral cortex of the tibial metaphysis.The proximal tip of the screw appears slightly backed out with positioning at the level of the anterior intercondylar notch.Linear radiodensity in the medial compartment joint space is likely related to the normal appearance of the polyethylene lining.Bones appear intact and normally mineralized.The left knee imaging demonstrates moderate to severe degenerative arthritic changes with joint space loss in the medial compartment.Possible backing out of the screw in the proximal tibia with the proximal head located in the anterior intercondylar notch.It is uncertain if this is related to subsidence/loosening from a previous time point.A definitive diagnosis can be made by comparing with previous imaging.Otherwise, the unicompartmental knee arthroplasty appears intact without periprosthetic lucencies.No fractures were detected.The overall fit alignment of the implants, as well as bone quality, appears normal.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.

• Brand Name: OXF UNI TIB TRAY SZ C RM PMA
• Type of Device: KNEE PROSTHESIS
• 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: 16804964
• MDR Text Key: 313904216
• Report Number: 3002806535-2023-00121
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388899
• UDI-Public: (01)05019279388899(17)271001(10)007610
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 154723
• Device Catalogue Number: 154723
• Device Lot Number: 007610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 83 KG