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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.Concomitant medical products: medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 384120.Medical product: unknown oxford tibial component, catalog #: unknown , lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to dislocated bearing was performed.

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, g4, g7, h1, h2, h10.D11: medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 384120 medical product: oxford pks cemented tibia component, catalog #: 154776, lot #: 2971256 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to dislocated bearing was performed.Additional information received: patient information associated product information (item number :(b)(6) and lot:2971256).

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.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: eight radiographs were provided with (b)(4): three mediolateral radiographs, three anteroposterior radiographs and two skyline radiographs.An email communication provided on etq specifies that three of the provided radiographs were taken after the primary surgery, three radiographs were taken after the bearing dislocation and before revision, whilst two radiographs were taken after the bearing revision and are therefore considered not relevant for this assessment.The exact dates on which the provided radiographs were taken are unknown.On the anteroposterior post-primary radiograph, 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 with or to have less than 2 mm overhang from the medial edge of the tibial plateau.In addition, the position of the medial x-ray marker ball on this radiograph suggests that the polyethylene bearing was partially 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.The cement mantle appears uneven below the tibial tray.The quality of the provided mediolateral post-primary radiograph does not allow for the full assessment of the fit and positioning of components.However, a large particle is visible within the posterior joint space, which could be a detached osteophyte, bone cement or the fabella.This feature is also visible in the other two mediolateral radiographs taken at later time points.The position of the polyethylene bearing x-ray markers in the three pre-revision radiographs demonstrate that the component had dislocated laterally within the anterior joint space, thus confirming the reported complaint of bearing dislocation.The provided oxford partial knee warranty claim form informs that the initial 4 mm bearing was changed to a thicker 6 mm bearing during revision, which suggests that some degree of soft tissue laxity may have been present.Information available on etq reports that the patient is male, was 62 years old at the time of the primary surgery, is 1.80 m tall and weighs 123.94 kg, thus his bmi suggests he is clinically obese.The instructions for use document included with the dislocated polyethylene bearing provided the following information: warnings: 1.Improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.6.Care is to be taken to ensure complete support of all parts of the device embedded in bone cement to reduce risk of stress concentrations, which may lead to failure of the procedure.Complete preclosure cleaning and removal of bone cement debris, metallic debris, and other surgical debris at the implant site is critical to minimize wear of the implant articular surfaces.8.Patients should be warned of the impact of excessive loading that can result if the patient is involved in an occupation that includes substantial walking, running, lifting, or excessive muscle loading due to weight that place extreme demands on the knee and can result in device failure or dislocation.Precautions: 2.Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients.While these devices are generally successful in attaining these goals they cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue.3.Excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of the implant by loosening, fracture, dislocation, subluxation and/or wear.Possible adverese events: 13.Dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.A review of the complaint database over the last 3 years has found no similar complaints reported with these item and lot combination.A review of the complaint database over the last 3 years has found 3 similar complaints reported with these item.No trend identified.The manufacturing history records (mhrs) of the dislocated oxford bearing and associated components have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.It is not possible to confirm the root cause for the bearing dislocation based on the provided information and before the revised bearing is received for evaluation.However, the patient high bmi, sub-optimal positioning of components, sub-optimal cementing technique, and soft tissue laxity may have been contributing factors to the bearing dislocation.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: risk management report documents the estimated residual risk associated with the device within the reported event.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 reported event states revision due to dislocated bearing.In the risk file, dislocation is considered harm with a severity level of 3 for a number of hazards defined as moderate, which is described in the severity table as: s-3 prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.Therefore, the outcome of the reported event (surgical intervention) is in line with 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.Product has not been returned.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to dislocated bearing was performed.

• Brand Name: OXF ANAT BRG RT MD SIZE 4 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: 10377925
• MDR Text Key: 202001348
• Report Number: 3002806535-2020-00367
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2020

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 Expiration Date: 08/03/2023
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 334940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/24/2020; 10/07/2020
• Supplement Dates FDA Received: 09/07/2020; 10/13/2020
• 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 Age: 63 YR
• Patient Weight: 124