MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.5 MM FEMALE HEX SCREW 25 MM LENGTH; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: articular surface fixed bearing posterior stabilized, p/n 42512401012, l/n 62401259; femur cemented posterior stabilized, p/n 42500607001, l/n 62330608; tibia cemented 5 degree stemmed, p/n 42532008301, l/n 62625812.(b)(6).The device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 03364, 3007963827 - 2018 - 00102, 0002648920 - 2018 - 00502.

Event Description

It was reported the patient experienced infection approximately two months post left knee arthroplasty and was eventually revised four years post implantation after previous unsuccessful treatments.No additional patient consequences were reported.

• Brand Name: 2.5 MM FEMALE HEX SCREW 25 MM LENGTH
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7626785
• MDR Text Key: 111975539
• Report Number: 0001822565-2018-03383
• Device Sequence Number: 1
• Product Code: HWD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42509902525
• Device Lot Number: 62824343
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2014
• 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): Hospitalization; Required Intervention