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

Model Number N/A

Device Problems Degraded (1153); Detachment of Device or Device Component (2907); Naturally Worn (2988); Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 00599401492 - femoral component option for cemented use only size d right - 63431965; 00599003420*op1000 - prc agmt block dist sz d 10mm - 63880048; 00599003420*op1000 - prc agmt block dist sz d 10mm - 63162325; 00598801013 - stem extension straight 13mm dia x 100mm length(combined length 145mm) - 63959225; 00598002701 - stemmed tibial component precoat size 1 for cemented use only use of this tibial component with lcck articulating surfaces requires using a stem exten - 62785418; 00598800126 - tibial half block augment precoat size 1 5 mm thickness - 63917559; 00598802011 - stem extension offset 11mm dia x 100mm length(combined length 145mm) - 63845553.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00973.

Event Description

It was reported that the patient underwent a right knee surgery and approximately 5 years later, experienced sudden onset of pain, clicking, and swelling of the right knee.Subsequently, the patient underwent a revision as the screw from the lcck poly had backed all the way out of the poly and was in the back of the knee.All of the threads were noted to be worn.Only the poly insert was exchanged.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the articular surface and the locking screw removed.The locking screw appears to be damaged.No further conclusions could be made without the device being returned.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: images show locking screw loose with liner dislodged, no sign of infection and other implants were well fixed, metallosis found, the screw was found in the back of the knee and poly insert was easy to remove.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: ARTICULAR SURFACE WITH LOCKING SCREW
• 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: 14014150
• MDR Text Key: 288599528
• Report Number: 0001822565-2022-00972
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00599402212
• Device Lot Number: 61842102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2011
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 77 KG