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

Model Number N/A

Device Problems Fracture (1260); Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Scar Tissue (2060); Synovitis (2094); Foreign Body In Patient (2687)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref 5988-10-14 lot 64244974 ng schaft 14x145 ref 599401792 lot 64117721 lcck femur links ref 599003720 lot 62788444 augment g 10 ref 598994702 lot 64272656 tibia ref 598802012 lot 63810594 stem 12x145.Foreign country: germany.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 patient underwent initial right total knee arthroplasty.Subsequently, the patient was revised approximately 3 years post implantation due to implant fracture.During the revision, implant wear, scar tissue, synovitis, instability, and loosening were noted.Unable to remove portion of screw and was retained in tibia.The inlay was exchanged.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the explanted product shows nicks and gouges with fractured support screw.Fractured screw was submitted for further analysis.Analysis determined fatigue striation and ductile overload dimples, which suggest rotational fatigue failure mode.The material analysis found screw material is consistent with the specifications.Device history record was reviewed and no discrepancies related to the reported event were found.Revision operative notes were provided and reviewed by a health care professional.Review of the available records identified articular surface was fractured and articular surface was loose.Scar tissue with massive synovitis was noted.Part of the fractured screw was left in the tibial plate.The articular surface was revised to a larger articular surface without a support screw as the part of the previous screw cannot be removed from the tibial plate.Root cause was unable to be determined.Per package insert, instability and fracture of the implant are known adverse effect of the system.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 at time of this report.

• Brand Name: ARTICULAR SURFACE WITH LOCKING SCREW
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15048860
• MDR Text Key: 296128769
• Report Number: 0001822565-2022-02102
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/27/2022

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 Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00599404212
• Device Lot Number: 63112850
• 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: 07/07/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 122 KG