MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ C LM; OXFORD CEMENTLESS TIBIAL TRAYS

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Osteolysis (2377)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Associated products: medical product: unk oxford femoral component, catalog no.: unknown, lot no.: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00346.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient presented with massive osteolysis in the distal femur.The implanted date is approximative, the operation was in another country and there was no patient file accessible.The patient presented with a fracture on the external condyle with a huge osteolysis in the distal femur on (b)(6) 2021.The fracture was provoked by fragility of the bone due to the osteolysis.The patient was revised to rhk on (b)(6) 2021.

Event Description

It is reported that the patient presented with massive osteolysis in the distal femur.The implanted date is approximative, the operation was in another country and there was no patient file accessible.The patient presented with a fracture on the external condyle with a huge osteolysis in the distal femur on (b)(6) 2021.The fracture was provoked by fragility of the bone due to the osteolysis.The patient was revised to rhk on (b)(6) 2021.

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: 3002806535-2021-00346-1.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.The device is used for treatment.The reported products were reviewed for compatibility with no issues noted.A review of complaint history found no additional related issues for item #159558 and the reported part and lot combination.Item and lot identification are necessary for review of device history records, the lot number was not provided for item #166574.Radiographs were provided with (b)(4): consisting of ap and lateral views of the left knee and a 3-d surface reconstruction from ct of the left knee.Mmi review identified extensive distal femoral osteolysis and a fracture of the lateral femoral condyle which supported the reported event.The implant fit appeared to be maintained despite the distal femoral osteolysis.Regarding alignment, the tibial implant was laterally positioned in relation to the femoral implant and knee valgus was evident.No definite loosening of the implants could be seen despite the extensive radiolucency secondary to osteolysis.Based on the available information, the fracture of the lateral femoral condyle was most likely caused by implant malalignment and the knee valgus.Other contributing factors cannot be discussed without examination of the revised components; these have not been returned to zimmer biomet for evaluation at the time of writing this assessment.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.If any additional information becomes available, then the complaint will be reopened and further investigated.H3 other text : product not returned.

• Brand Name: OXF UNI CMNTLS TIB SZ C LM
• Type of Device: OXFORD CEMENTLESS TIBIAL TRAYS
• 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: 12340969
• MDR Text Key: 267214882
• Report Number: 3002806535-2021-00347
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: 166574
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: No
• 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: SEEH10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG