MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD ANT STBLZD BRG 16X75; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 05/13/2019

Event Type  Injury  

Event Description

It was reported that a patient's articular surface was revised approximately one year post implantation due to instability.There is no additional information available.

Manufacturer Narrative

(b)(4).D10- medical product bmt splined knee stm v2 13x160, item# 148327, lot# 600100.Vg 360 dst fm ag 70x10 rl/lm, item# 185386, lot# 66059614.Vg 360 dst fm ag 70x10 ll/rm, item# 185406, lot# 66044535.Vg 360 univ pst fm aug 70x5, item# 185346, lot# 66303815.Vngd ssk psc tib brg 16x71/75, item# 183886, lot# 66280240.Biomet tibial locking bar , item# 141205, lot# 66177055.H3- customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: VNGD ANT STBLZD BRG 16X75
• 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: 18921921
• MDR Text Key: 337876410
• Report Number: 0001825034-2024-00700
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2019
• Device Model Number: N/A
• Device Catalogue Number: 189086
• Device Lot Number: 692120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2014
• 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: Female