MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FEMORAL AUGMENT 10MM; PROSTHESIS, KNEE

Device Problems Material Erosion (1214); Fracture (1260); 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  

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

(b)(4).D10: medical product: unknown rotating hinge knee femoral component: catalog#ni, lot#ni; long 16mm diameter 155mm length straight stem extension combined length 200mm: catalog#00598801116, lot#62292125; unknown femoral augment 10mm: catalog#ni, lot#ni; unknown rotating hinge knee tibial tray: catalog#ni, lot#ni; 17mm height size d articular surface with hinge post extension: catalog#00588004017, lot#65566971.G2: foreign: germany.Additional mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-02922; 0002648920-2023-00317; 0001822565-2023-02924; 0001822565-2023-02925.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.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.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

An additional mdr report was filed for the subsequent revision surgery involving this device.Please see associated report: 0001822565-2024-01082.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.The femoral augments and bone cement remain attached/connected to the femoral component.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 as the necessary information to adequately investigate the reported event was not provided.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: UNKNOWN FEMORAL AUGMENT 10MM
• 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: 18375214
• MDR Text Key: 331125917
• Report Number: 0001822565-2023-03757
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• 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
• Report Date: 03/28/2024

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male