MAUDE Adverse Event Report: BIOMET UK LTD. RHK BEARING 12 FOR 63-67 TRAY; TIBIAL INSERT

Model Number N/A

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical devices: medical product: rhk right sml resurf femur r, catalog #: 154975, lot #: unknown; medical product: rhk short hinge assembly, catalog #: 161583, lot #: unknown; medical product: bmt splined knee stm 16x120, catalog #: 141656, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00448, 3002806535-2020-00450.Limited patient information due to data protection.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 the surgeon wanted to try to re-implant the screw and change the pe components with yoke and axle.During the surgery, a massive metallosis was visible and the femoral part sat loosely on the femoral shaft, the screw could be easily removed.Due to the abrasion on the shaft cone, it was no longer usable for further anchorage and had to be removed.Subsequently, a revision procedure was performed on (b)(6) 2020 (oss segmental distal femur used).Right side involved.120 min delay: the femoral stem had to be explanted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d8, g3, g6, h1, h2, h6, h10.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00448-1, 3002806535-2020-00450-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Radiographs: one mediolateral radiograph of the patient right knee, taken on an unknown date, was provided for analysis with cmp-0632131.The rhk components appear adequately sized.The screw used to lock the femoral stem to the femoral component is positioned anteriorly to the tibial tray bearing in the radiograph.A large bone fragment appears to have broken from the posterior side of the distal end of the femur.This is in agreement with the complaint description of poor femoral implant fixation: the femoral part sat loosely on the femoral shaft, the screw could be easily removed.The rhk surgical technique mentions that the surgeon should insert the screw packaged with the femur between the condyles and tighten firmly during the femoral component assembly.Intraoperative photographs provided with cmp-0632131 show extensive tissue blackening around the implants, which is indicative of metallosis, in agreement with the complaint description.Linked complaint (b)(4) is a duplicate of (b)(4).Linked complaint (b)(4) refers to the warsaw design components.A case report by medical metrics inc., dated 5-oct-2020, confirms that there is a screw anterior to the proximal tibia and an age-indeterminate mildly displaced periprosthetic fracture posterior to the distal femoral cortex.The zimmer biomet product experience report (zper) states that the rhk knee was implanted on an unknown date, and the surgery reported in (b)(4) occurred on (b)(6) 2020.The femoral component, femoral stem and polyethylene bearing were removed and a hand-made cement spacer with pe inlay were implanted to protect the remaining tibial components.The zper also mentions that the product has malfunctioned, and that there was a delay of 120 minutes during surgery due to the device, as the femoral stem had to be explanted for hours.Finally, the zper states that it is unknown whether there were any contributing conditions related to the event.Additional information received states: the pain was the cause of the revision.Since there were no implants of this size during this operation, the defect was temporarily bridged with a cement spacer and we got them on (b)(6).The patient was operated with a 15 cm shaft, 3 cm segment and 5 cm femur.The patient is fine and if nothing is infected she will go home the next week.The patient, female, was 1.60 m tall and weighed 100 kg, thus having a bmi of 39.1 (obese).Further patient details such as age and activity level are not available due to country regulations.The manufacturing history records (mhrs) for all components were unavailable as lot numbers are not available.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: risk management plan 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 table could not be selected for comparison.The reported event states revision surgery (due to loosening and metallosis).These hazards have a severity of 4 which is described in the severity table as: s-4 results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.The reported event (surgical intervention) is considered to be within the severity of the rmf.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 years prior to notification date, being september 2020.1.For item 154975, lot unknown: - sales (september 2017 ¿ september 2020) = (b)(4) units.- no other complaints were identified for this item number other than (b)(4).- therefore, the calculated occurrence rate is 1 in (b)(4).- since the occurrence calculation is based on only (b)(4) item sales, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a meaningful calculation based on (b)(4) item sales.The failure mode will be monitored through zimmer biomet internal complaint and post market surveillance activities with further review of risk conducted through these processes.2.For item 159430, lot unknown: - sales (september 2017 ¿ september 2020) = (b)(4) units.- no other complaints were identified for this item number other than (b)(4).- therefore, the calculated occurrence rate is 1 in (b)(4).- since the occurrence calculation is based on only (b)(4) item sales, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a meaningful calculation based on (b)(4) item sales.The failure mode will be monitored through zimmer biomet internal complaint and post market surveillance activities with further review of risk conducted through these processes.3.For item 161583, lot unknown: - sales (september 2017 ¿ september 2020) = (b)(4) units.- no other complaints were identified for this item number other than (b)(4).- therefore, the calculated occurrence rate is 1 in (b)(4).- since the occurrence calculation is based on only (b)(4) item sales, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a meaningful calculation based on (b)(4) item sales.The failure mode will be monitored through zimmer biomet internal complaint and post market surveillance activities with further review of risk conducted through these processes.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 the surgeon wanted to try to re-implant the screw and change the pe components with yoke and axle.During the surgery, a massive metallosis was visible and the femoral part sat loosely on the femoral shaft, the screw could be easily removed.Due to the abrasion on the shaft cone, it was no longer usable for further anchorage and had to be removed.Subsequently, a revision procedure was performed on (b)(6) 2020 (oss segmental distal femur used).Right side involved.120 min delay: the femoral stem had to be explanted.

• Brand Name: RHK BEARING 12 FOR 63-67 TRAY
• Type of Device: TIBIAL INSERT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10688918
• MDR Text Key: 211646167
• Report Number: 3002806535-2020-00449
• Device Sequence Number: 1
• Product Code: HRY
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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: 159430
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2021
• 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: 100