MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 5 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/29/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted.Concomitant medical product: medical product: unknown oxford tibial component, catalog #: unknown, lot #: unknown; medical product: unknown oxford bearing, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00362, 3002806535-2020-00364.Occupation: clinical project lead.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.

Event Description

It was reported by (b)(6) study group that subject ale-1018 passed away of pancreatic cancer on (b)(6) 2020.The subject r knee was revised in 2015, but the l knee was still in the study.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a2, a4, b4, b5, b7, d1, d2, d4, d6, g4, g5, g7, h1, h2, h4, h5, h8, h10.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00362-1, 3002806535-2020-00364-1.Additional information: hospital name: (b)(6).Information obtained from the case report form: left knee: date of surgery: (b)(6) 2014.Reason- pain,osteoarthritis.Implant details: 161474 2407049; 159549 2845936; us166574 3050468.Hospital: (b)(6).Complication1: (b)(6) 2014-left knee pain; treatment-quad strengthening, nsaids, activity modification.Complication2: (b)(6) 2014 -right knee-4wk severe pain, xrays show subsidence of tibial implant, increase.Posterior slope 9 to 20 degrees, change in varus from 0 to 2 degrees.Valgus.Aseptic loosening, early collapse r tibial comp.Treatment-medication, home exercises.Revision- (b)(6) 2015.Complication 3: (b)(6) 2014-left- severe pain at 4wk f/u.Xrays show position change of tibial implant.From 4 degrees slope to 10 degrees, from 2 degrees valgus to 10.Degrees valgus.Treatment: medication home exercise.Complication 4: (b)(6) 2018-left-s/p right tha with bursitis; treatment: ibuprofen, stretching, physical therapy.Complication 5: (b)(6) 2018-left-right knee clicking it band; treatment: ibuprofen, stretching, physical therapy.Complication 6: (b)(6) 2019-left¿pancreas cancer; treatment-surgical treatment.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by oxford clinical study group that subject ale-1018 passed away of pancreatic cancer on (b)(6) 2020.The subject r knee was revised in 2015, but the l knee was still in the study.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2020-00362-2, 3002806535-2020-00364-2.As the product has not been received, the investigation was limited to the information provide.Radiographs: eleven radiographs were provided for analysis with (b)(4), taken at the 6-week, 6-month, 1-year, 2-year, 3-year and 4-year follow-up visits.One anteroposterior (ap) and one mediolateral (ml) radiograph were taken at each follow-up visit, except at 6 months when only one ap radiograph was taken.All provided ap radiographs show the tibial component at a valgus angle relative to the tibia.The medial edge of the tibial tray appears to be short of the medial edge of the tibial plateau.The oxford partial knee surgical technique recommends the medial edge of the tibial tray to be flush or with less than 2 mm overhang from the medial edge of the tibial plateau.The position of the medial x-ray marker ball indicate that the meniscal bearing may have been overhanging from the medial edge of the tibial tray.The oxford partial knee surgical technique recommends the bearing markers to be central and parallel with the tibial component.On the ml radiographs, the posterior edge of the tibial tray appears to be short of the posterior edge of the tibial plateau.The oxford partial knee surgical technique recommends the posterior edge of the tibial tray to be flush or with less than 2 mm overhang from the posterior edge of the tibial plateau.Some debris such as osteophytes and/or bone fragments may also be present in the anterior and posterior joint space.The manufacturing history records (mhrs) of all components have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.The kss assessment and functional scores, and the oxford knee scores recorded within the case report form (crf) varied between follow-up assessments, with the patient indicating to be satisfied with the operated knee at the 6-week and 1-year appointments, and either uncertain or unsatisfied at the other appointments.The adverse event dated (b)(6) 2014 described as x-rays show position change of tibial implant from 4 degrees slope to 10 degrees, from 2 degrees valgus to 10 degrees valgus indicates that the observed subsidence of the tibial tray occurred approximately 4 weeks after surgery.It has been reported that sub-optimal tibial plateau preparation and sub-optimal fit of the tibial tray may lead to tibial fracture and tibial tray subsidence in oxford cementless systems.The reported death of the patient with pancreatic cancer was not related to the device.A review of the complaint database over the last 3 years has found no similar complaints reported with item and lot combination.A review of the complaint database over the last 3 years has found no similar complaints reported with these items.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports death due to pancreatic cancer.X-ray review request states that the reported death of the patient with pancreatic cancer was not related to the device, therefore a risk assessment has not been performed.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.Product has not been returned.

Event Description

It was reported by oxford clinical study group that subject (b)(6) passed away of pancreatic cancer on (b)(6) 2020.The subject r knee was revised in 2015, but the l knee was still in the study.

• Brand Name: OXF ANAT BRG LT MD SIZE 5 PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10366622
• MDR Text Key: 201667131
• Report Number: 3002806535-2020-00363
• 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: other,study
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 159549
• Device Lot Number: 2845936
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10
• Patient Outcome(s): Death
• Patient Weight: 79