MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE RIGHT SIZE D FEMORAL COMPONENT; PROSTHESIS, KNEE

Catalog Number 00588001402

Device Problems Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: unknown femoral stem: catalog#ni, lot#ni; unknown femoral cone: catalog#ni, lot#ni; unknown rotating hinge knee tibial tray: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni.G2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-02923; 0001822565-2023-02924; 0001822565-2023-02925.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.

Event Description

It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.Subsequently, the patient developed metallosis and loosening of the femoral component.It is also suspected that the connection between the femoral stem and femoral cone implants is fractured.A revision surgery is pending to replace the affected components.Due diligence is in progress for this event, to date no further information has been reported.

Event Description

It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.On an unknown timeframe post-implantation, the patient developed metallosis and loosening of the femoral component.It was also suspected that the connection between the femoral stem and femoral cone implants is fractured.Subsequently, the patient underwent revision surgery of the femoral components.Due diligence is in progress for this event, to date no further information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: medical product: long 16mm diameter 155mm length straight stem extension combined length 200mm: catalog#00598801116, lot#62292125; unknown femoral augment 10mm: catalog#ni, lot#ni, qty#2; unknown rotating hinge knee tibial tray: catalog#ni, lot#ni; 17mm height size d articular surface with hinge post extension: catalog#00588004017, lot#65566971.Additional mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-03757.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: d1; d2; d4; d9; g3; g4; h2; h3; h10.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

No further event information at time of this report.

Event Description

It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.On an unknown timeframe post-implantation, the patient developed metallosis and loosening of the femoral component.It was suspected that the connection between the femoral stem and femoral cone implants fractured.Subsequently, the patient underwent additional surgery to re-cement the femoral components and they were left in place.A full revision surgery was planned for a later date.Due diligence is complete as multiple attempts have been made however no further information has been made available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b3; b4; b5; d10; g3; h2; h3; h6; h10.H6: proposed component code: mechanical (g04) - femur.An additional mdr report was filed for the subsequent revision surgery involving this device.Please see associated report: 0001822565-2023-03380.The reported device was returned to the manufacturer following explantation at a later date.The device was also evaluated pertaining to this event.Visual examination of the product identified signs of implantation.For the femoral implant, both bone cement and femoral augments remain attached/connected to the device.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.Reported event was unable to be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN ROTATING HINGE KNEE RIGHT SIZE D FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17985068
• MDR Text Key: 326265258
• Report Number: 0001822565-2023-02922
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013385
• 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,Followup,Followup
• Report Date: 03/28/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00588001402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Sex: Male