MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Edema (1820); Swelling (2091)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Medical product: oxf anat brg lt sm size 3 pma, catalog #: 159540, lot #: 086670.Medical product: oxf uni tib tray sza lm, catalog #: 154718, lot #: 2371090.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00303, 3002806535-2020-00304.Occupation: clinical study group.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by clinical study group that patient (b)(6) underwent an initial left knee arthroplasty.Subsequently, the patient experienced an increase in left knee swelling.Betamethasone injection was administered to the left knee on (b)(6) 2020 to treatment the swelling.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00303-1, 3002806535-2020-00304-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Radiographs: seventeen radiographs were provided with (b)(4): one mediolateral and one anteroposterior radiograph for each follow-up visit at 6 weeks, 6 months, 1 year, 3 years, 4 years, 5 years and 6 years; an additional tunnel view radiograph was also provided for each follow-up visit at 4, 5 and 6 years.It is reported in the case report form (crf) that the patient did not attend the 2-year visit, therefore the related radiographs and information were not collected.Additional information, i.E.6-year radiographs and surgical notes, was received on 16-sep-2020.The surgical notes state that there were no apparent complications during surgery.The orientation of the left knee in the anteroposterior radiographs taken at 6 weeks, 6 months and 1 year does not allow for the full assessment of the fit and positioning of components.The oxford surgical technique recommends to, before taking the film, adjust the position of the limb by flexing/extending the knee and internally/externally rotating the leg until the tibial component appears on the screen directly end-on.On the radiographs taken at 3 years, 4 years, 5 years and 6 years, the cement mantle below the tibial tray appears uneven, and a gap or radiolucent line appears to be present between the vertical wall of the tibial tray and the vertical cut of the tibia.The oxford surgical technique recommends the vertical wall of the tibial tray to be flush with the vertical tibial cut, with no gap.In addition, on these latest radiographs, the medial edge of the tibial tray appears to be overhanging from the medial edge of the tibial plateau.The oxford surgical technique recommends the medial edge of the tibial tray to be flush with or to present less than 2 mm overhang from the medial edge of the tibial plateau.On the mediolateral radiograph taken at the 6-week appointment, a large particle (likely bone, bone cement or an osteophyte) is present within the posterior joint space.The large particle is not visible on any of the radiographs taken at the later follow-up visits.The fit and positioning of components appears in accordance with the recommendations in the oxford surgical technique.Bone density below the tibial tray, in particular in the medial side as seen in the anteroposterior radiographs, and anteriorly as seen in the mediolateral radiographs, appears to be lower on the 4-, 5- and 6-year radiographs compared to previous radiographs.On the mediolateral radiograph taken during the 6-year visit, a radiolucent feature appears to be present between the posterior portion of the femoral component and bone.It is not clear what the feature represents, and the quality of the radiographs taken at the previous appointments does not allow to confirm if this was already present at earlier time-points.The crf informs that the patient is female, was 74 years old at the time of surgery, is 1.52 m tall and weighs 59 kg, therefore her bmi is 25.5 (overweight).The patient kss and oxford knee scores were excellent at the 6-week, 6-month and 1-year follow-up visits, with the patient being either very satisfied or satisfied with the operated knee.The patient did not attend the 2-year visit, and lower kss and oxford knee scores were recorded during all the following appointments, with the patient being either uncertain or unsatisfied with the operated knee.The crf informs that confounding conditions were identified starting from the 2-year time-point that affected the patient knee: myeloma treated with chemotherapy, bursitis, lateral compartment arthritic disease and sjogren syndrome.The additional tunnel view radiographs taken at the 4-year, 5-year and 6-year visits show bone-on-bone contact in the lateral compartment, thus confirming the reported arthritic disease in the lateral compartment.The manufacturing history records (mhrs) of all components were checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.Based on the available information, it appears that sub-optimal cementing technique, sub-optimal fit and positioning of components, and co-existing conditions affecting the patient knee, including progression of arthritis in the lateral compartment, may have contributed to the reported swelling.A review of the complaint database over the last 3 years has found no similar complaints reported with these items 159540,154718 and 161468.A review of the complaint database over the last 3 years has found no similar complaints reported with these item and lot combination.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The complaint summary states: based on the available information, it appears that sub-optimal cementing technique, sub-optimal fit and positioning of components, and co-existing conditions affecting the patient¿s knee, including progression of arthritis in the lateral compartment, may have contributed to the reported swelling.Risk management report documents the estimated residual risk associated with the reported event.The reported event states: increase in left knee swelling.In the risk file, swelling/edema is considered harm with a maximum severity level of 3 for a number of hazards defined as moderate, which as per the severity table listed within the rmr is defined as prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (medical intervention) is considered to be within the severity of the rmf.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported by clinical study group that patient ((b)(6)) underwent an initial left knee arthroplasty.Subsequently, the patient experienced an increase in left knee swelling.Betamethasone injection was administered to the left knee on (b)(6) 2020 to treatment the swelling.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10233125
• MDR Text Key: 197586138
• Report Number: 3002806535-2020-00305
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438228
• UDI-Public: 05019279438228
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 161468
• Device Lot Number: 055890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 59