MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL FEMORAL XT COMPONENT SIZE B LEFT USE WITH POLYETHYLENE INSERT XT SIZE B; PROSTHESIS, KNEE

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); Pain (1994); Numbness (2415); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526)

Event Date 01/29/2024

Event Type  Injury  

Event Description

It was reported that the patient underwent a left knee revision approximately 22 months post implantation due to pain and dissatisfaction returning to previous activity levels.Radiographic imaging demonstrated concern for femoral loosening, and this was confirmed intra-operatively.The femoral component and poly were exchanged without known complications.

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-00697, 0001822565-2024-00699.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed component (annex g) code is mechanical (g04) - femur.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pre-op office visit: ct results: no acute bony abnormality, no evidence of fracture, no definite evidence of osteolysis or loosening however the bone around the prosthesis shows diffuse bony demineralization; patient¿s biggest complaint is medial pain and inability to resume normal previous activities, also states some numbness to sole of her foot has returned; revision surgical notes: the femoral stem was rotationally loose, the tibia was well fixed, no signs of infection, reasonably healthy bone quality a definitive root cause cannot be determined.Complaint is confirmed with the provided medical records.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: DISTAL FEMORAL XT COMPONENT SIZE B LEFT USE WITH POLYETHYLENE INSERT XT SIZE B
• 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: 18792364
• MDR Text Key: 336370109
• Report Number: 0001822565-2024-00698
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585004201
• Device Lot Number: 65244875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 82 KG