MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEX ARTICULAR SURFACE LOCKING SCREW; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products and mdrs, concomitant medical products: 00596403017, articular surface with locking screw size cd 17 mm height, lot#: 63939062.Mdr: 0001822565-2021-00288.

Event Description

It was reported that the patient hadn't had any issue with her knee until taking a fall.Since the fall she had been experiencing instability and a 'clicking feeling' when she would walk.The pain was not severe enough for her to seek medical attention.She felt the pain and clicking were worsening so went to be seen by dr for evaluation.Upon reviewing x-rays, it was obvious that the poly locking screw was out of place and needed to be revised.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.Radiographs were provided and x-ray evaluation by third party healthcare professional confirms that the locking screw was displaced.Review of the available radiographs identified the following: knee alignment is maintained with no facture; the poly locking screw is displaced and extends into the knee joint; bone quality is osteopenic.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

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

• Brand Name: FLEX ARTICULAR SURFACE LOCKING SCREW
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11262631
• MDR Text Key: 229871465
• Report Number: 0001822565-2021-00292
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K043101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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: 00595009000
• Device Lot Number: 62774916
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 82