MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD SSK PSC FMRL STEM SCREW; PROSTHESIS, KNEE

Model Number N/A

Device Problems Noise, Audible (3273); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 : (b)(6)- biomet smooth knee stems 22x40 - unknown.(b)(6) - tnbn vg ssk/da360 rh fem 67.5 - (b)(6).(b)(6) - vngd ssk psc tib brg 14x71/75 -(b)(6).G2 : foreign country : switzerland.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 knee surgery.Subsequently, the patient reported hearing noise upon flexion.X-rays were taken and it was found that the femoral screw had backed out and the patient underwent a revision surgery approximately 2.5 years postop.The surgeon noted that the femoral component showed no scratch marks and both the tibial and femoral components did not show signs of loosening.The screw was removed and was not replaced.A plug connection was placed and the inlay was replaced.Attempts have been made and all available information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d4; d9; d10; g1; g3; g6; h1; h2; h3; h4; h6 d10: 183884 - vngd ssk psc tib brg 14x71/75 - unknown 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.

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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.D10: 145012 - biomet smooth knee stems 22x40 - 227410.183884 - vngd ssk psc tib brg 14x71/75 - 898670.185211 - bmt 360 tib 5.0 offset adapter - 500020.141484 - biomet offset tibial tray 75mm - 348570.141491 - offset tib tray 5.0mm adaptor - 227410.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

• Brand Name: VNGD SSK PSC FMRL STEM SCREW
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18597215
• MDR Text Key: 334027454
• Report Number: 0001825034-2024-00170
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K171054
• 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: 03/14/2024

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
• Device Model Number: N/A
• Device Catalogue Number: 183315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/06/2024; 02/23/2024; 03/07/2024
• Supplement Dates FDA Received: 02/14/2024; 03/06/2024; 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2019
• 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.; SEE H10.; SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 83 KG