MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; UNKNOWN KNEE ARTHROPLASTY

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 that a patient underwent an initial knee arthroplasty approximately 20 years ago.Subsequently, a revision procedure due to fractured bearing along the opaque bar line was performed.Patient reported great outcome from prosthesis until he turned awkwardly.

Manufacturer Narrative

(b)(4).This final / follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h10.Correction: incorrectly reported on (b)(6)2020: email received stating no further information is available for siris outlier cases.This complaint is not related to siris outlier cases.Further information requested, however email received stating that product numbers are not available.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that a patient underwent an initial knee arthroplasty approximately 20 years ago.Subsequently, a revision procedure due to fractured bearing along the opaque bar line was performed.Patient reported great outcome from prosthesis until he turned awkwardly.

Manufacturer Narrative

(b)(4).E3: occupation: post market surveillance senior specialist.G3: report source, foreign - event occurred in australia.Email received stating no further information is available for siris outlier cases.Initially reported product with no:159576 and lot no:6574989 (replacement bearing, manufactured in 2019).However it was reported that the initial knee arthroplasty was done approximately 20 years ago.Therefore, the product initially reported (no:159576 and lot no:6574989) is not the original implanted bearing component.Further request for product number of initially implanted bearing component was requested, and reply received that information about the initially implanted product is not available.Summary: as the product has not been received, the investigation was limited to the information provided.Two pre-revision radiographs, one anteroposterior and one mediolateral, were provided with (b)(4), which were taken on (b)(6) 2020.Immediate post-surgery radiographs were not provided and are required for the assessment of the initial fit and positioning of components.On both provided radiographs, the metal components appear to be in contact.The fracture of the polyethylene bearing is confirmed by the presence of one marker wire within the anterior joint space, below the patella (visible on both the anteroposterior and the mediolateral radiograph), and of the second marker wire within the posterior joint space (visible on the mediolateral radiograph), indicating that the bearing had split into two fragments.A photograph of the explanted polyethylene bearing available on zb global quality system shows that the component had fractured across its width, along the posterior marker wire.On the mediolateral radiograph, it appears that the tibial tray may be short posteriorly.The oxford partial knee surgical technique recommends the posterior edge of the tibial tray to be flush with or to have less than 2 mm overhang from the posterior edge of the tibial plateau.Osteophytes or third body debris are visible within the posterior and the medial joint space.Details of the fractured meniscal bearing could not be retrieved, therefore the manufacturing history records could not be checked to confirm that the part was manufactured and sterilised according to the applicable specifications.It is not possible to confirm the root cause of the bearing fracture without the explanted component being made available for examination.However, it is likely that the fracture occurred due to wear over the 20 years that the bearing was in service and was triggered when the patient turned awkwardly, as stated in the complaint description.An evaluation cannot be completed for this issue from the photographs provided.We have not been provided with any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the replacement bearing have been provided is not the original implant which has been reported to have fractured.The root cause of the reported bearing fracture has not been determined with the information provided.X-ray review has concluded that it is likely that the fracture occurred due to wear over the 20 years that the bearing was in service and was triggered when the patient turned awkwardly, as stated in the complaint description.The details of the original bearing implant have not been provided.Although the root cause can not be confirmed, the hazard of excessive loading of joint (accident or patient noncompliance) considers the hazardous situation of wear and particle release with a number of harms as potential outcomes.Harm of non-functioning joint is considered a severity of moderate-3 which as per the severity table within the rmr is defined as prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Therefore, the outcome of this complaint is as anticipated by the risk documentation.Corrective and preventive actions: 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 that a patient underwent an initial knee arthroplasty approximately 20 years ago.Subsequently, a revision procedure due to fractured bearing along the opaque bar line was performed.Patient reported great outcome from prosthesis until he turned awkwardly.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 PMA
• Type of Device: UNKNOWN KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10128009
• MDR Text Key: 194329155
• Report Number: 3002806535-2020-00282
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786220
• UDI-Public: 05019279786220
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNK BEARING
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 08/21/2020; 08/21/2020
• Supplement Dates FDA Received: 08/25/2020; 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 90