MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CEMENTLESS TIBIA B RM; KNEE PROTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Joint Swelling (2356)

Event Date 03/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.Medical product : oxf anat brg rt sm size 4 pma, catalog #: 159569, lot #: 193670.Medical product : oxf twin peg cmntls fmrl sm, catalog #: 161473, lot #: r2409853a.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00219, 3002806535-2020-00218.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.

Event Description

It was reported by crf report for study (b)(6) that the patient experienced tingling and in edema on right knee.No trauma reported.

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: 3002806535-2020-00219-2, 3002806535-2020-00218-2.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.X-rays reviews: fourteen radiographs were provided for analysis with (b)(4), taken at five different time points after the primary surgery: 6 weeks (one anteroposterior and one mediolateral), 6 months (one anteroposterior and two mediolateral), 1 year (one anteroposterior and two mediolateral), 2 years (one anteroposterior and two mediolateral) and 3 years (one anteroposterior and two mediolateral).Only ten radiographs showing the right knee (associated with complaint: (b)(4) have been assessed.The orientation of the knee in the provided anteroposterior radiographs does not allow for the full assessment of the fit, sizing and positioning of components.The oxford surgical technique recommends to position the patient supine on a standard fluoroscopic screening table with an undercouch tube and an image intensifier.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.The position of the medial x-ray marker ball in all anteroposterior radiographs suggests that the meniscal bearing may be overhanging medially; however, this cannot be confirmed due to the above mentioned sub-optimal views of the knee in the provided radiographs.The mediolateral radiographs of the right knee show adequately sized and positioned tibial and femoral components.Some third body feature is visible in the posterior joint space in all mediolateral radiographs.It is unclear if this is an osteophyte.Neither of the above observations are thought to be implicated in the cause of the edema that the patient has presented with.At the pre-operative visit (on (b)(6) 2016), the patient presented weight of 100.7 kg and a height of 1.55 m, thus having a bmi of 42 (clinically obese).The instructions for use provided with the cementless tibial tray and femoral components [2], and with the meniscal bearing provide the following relevant information: warnings: 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.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: biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function of many patients.While these devices are generally successful in attaining these goals they may not withstand the activity levels and loads of normal healthy bone joint tissue.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.The manufacturing history records (mhrs) for the oxford anatomic bearing, tibial tray and femoral component have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.The kss and oxford assessment scores were excellent at all post-operative visits from the 6-month visit, with the kss functional score reaching the maximum value (100) at the 1-year visit and remaining constant at this level throughout all following visits recorded in the provided crf.Moreover, it was reported that the patient was very satisfied with the operated knee at all visits over the 3 years after surgery.Three adverse events were reported in the case report form (crf).Two of them are not pertinent to the right knee.The adverse event related to (b)(4) occurred on (b)(6) 2020, approximately 3 years and 9 months after surgery.The root cause of the reported complaint of tingling and edema cannot be determined without provision of further radiographic, clinical and patient information.However, the adverse event was marked as not related to the device by the physician, and the event was recorded as tolerated with medication.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaint found for the items: 159569, 161473 and us166573.Without the opportunity to examine the complaint product, the 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.For item: 159569 lot: 193670: risk management report documents the estimated residual risk associated with the reported event.In the risk file, pain and 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.Clinical study notes state medication was prescribed as treatment, therefore the outcome of this complaint (medical intervention) is considered to be within the severity of the rmr.For item: 161473, lot: r2409853a and item: us166573, lot: r3050462a: risk management report documents the estimated residual risk associated with the reported event.In the risk file, pain and 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.Clinical study notes state medication was prescribed as treatment, therefore the outcome of this complaint (medical intervention) is considered to be within the severity of the rmr.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported by crf report for study oxford_u3030 that the patient experienced tingling and in edema on right knee.No trauma reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D11: medical product: oxf anat brg rt sm size 4 pma, catalog #: 159569, lot #: 193670.Medical product: oxf twin peg cmntls fmrl sm, catalog #: 161473, lot #: r2409853a.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00219-1, 3002806535-2020-00218-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaint found for the items 159569, 161473 and us166573.Without the opportunity to examine the complaint product, the 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.For item: 159569 lot: 193670: risk management report documents the estimated residual risk associated with the reported event.The reported event states swelling on right knee.In the risk file, pain and 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.Clinical study notes state medication was prescribed as treatment, therefore the outcome of this complaint (medical intervention) is considered to be within the severity of the rmr.For item: 161473 lot: r2409853a and item: us166573 lot: r3050462a: risk management report documents the estimated residual risk associated with the reported event.The reported event states swelling on right knee.In the risk file, pain and 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.Clinical study notes state medication was prescribed as treatment, therefore the outcome of this complaint (medical intervention) is considered to be within the severity of the rmr.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported by crf report for study oxford_u3030 that the patient experienced tingling and in edema on right knee.No trauma reported.

• Brand Name: OXFORD CEMENTLESS TIBIA B RM
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9932167
• MDR Text Key: 190129607
• Report Number: 3002806535-2020-00217
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• 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: US166573
• Device Lot Number: R3050462A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 101