MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNI FEMORAL COMPONENT HIGH FLEX PRECOAT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Pain (1994)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D6a : (b)(6) 2015.D10 : 00584202508 - articular surface size 5 8 mm height femoral size a,b,c,d,e,f,g - 62815104.00584200501 -tibial component precoat left medial/right lateral size 5 - 62823541.G2 : foreign country : france.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial surgery and approximately 9 years post-op, was revised due to pain.Intraoperatively, it was discovered that the femoral component was fractured in half.The poly and tibial component were also revised.Attempts have been made and all available information has been provided.

Event Description

It was further reported that the patient revised approximately 9 post-op for loosening.During the revision the femoral component was fractured and loose and wear was noted to the tibia component.Attempts have been made and all available information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: ZIMMER UNI FEMORAL COMPONENT HIGH FLEX PRECOAT
• 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: 18940108
• MDR Text Key: 338123988
• Report Number: 0001822565-2024-00977
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033363
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 00584201501
• Device Lot Number: 62742656
• 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: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 86 KG