MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CEMENTLESS TIBIA D LM; KNEE PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Swelling (2091)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00073, 3002806535-2019- 00074.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent initial left oxford knee arthroplasty.Subsequently, the patient suffered pain and swelling in the left knee.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Medical product: oxf twin peg cmntls fmrl lg catalog #: 161475 lot #: r3050589a.Medical product: oxf anat brg lt lg size 4 pma catalog #: 159555 lot #: 085320.X-ray review: in the mediolateral radiographs, the femoral component appears to be overhanging posteriorly.The oxford partial knee surgical technique recommends the posterior fit of the femoral component to be flush with, or with less than 4 mm overhang from the femoral edge.It is difficult to confirm the posterior fit of the tibial tray due to the projection of the radiographs, however it is possible that the tibial tray is overhanging posteriorly.The oxford partial knee surgical technique recommends the tibial tray to be flush with, or with less than 2 mm overhang from the posterior edge of the tibial plateau.There appears to be radiolucency present in the anterior tibia on the 6 month and following radiographs, beneath the anterior edge of the tibial tray.In the mediolateral radiographs taken 1 and 2 years after surgery, debris may be present anteriorly within the joint space.In the anteroposterior radiograph taken during the 6-month follow-up visit, the femoral component appears positioned and sized correctly.A gap is visible between the vertical wall of the tibial tray and the tibial vertial cut.The oxford partial knee surgical technique recommends the vertical wall of the tibial tray to be positioned flush with the tibial bone, with no gap.The x-ray marker balls and wire of the polyethylene bearing indicate that the component may be articulating along the medial edge of the tibial tray.The oxford partial knee surgical technique recommends the x-ray marker wire to be central and parallel with the tibial component.A comparison with the other anteroposterior radiographs taken at the previous and following visits is not possible due to the different orientation of the knee.With the available information, it cannot be determined whether the report of dull pain and swelling at the back of the knee is related to the device.However, it is noted that at the 2-year follow-up the patient had a kss assessment score of 95, and a kss functional score of 100 and an oxford knee score of 44, which can be considered as excellent.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 Description

It was reported that the patient underwent initial left oxford knee arthroplasty.Subsequently, the patient suffered pain and swelling in the left knee.

• Brand Name: OXFORD CEMENTLESS TIBIA D LM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8284330
• MDR Text Key: 134303403
• Report Number: 3002806535-2019-00075
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• 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: US166576
• Device Lot Number: R3050479A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other