MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 10MM HEIGHT SIZE E,F WITH LOCKING SCREW GREEN ARTICULAR SURFACE USE WITH FEMORAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/25/2023

Event Type  Injury  

Event Description

It was reported that during a total knee arthroplasty, the tip of the locking screw broke when the surgeon tightened the fixation screw of the articular surface with the torque wrench.He was not able to remove the broken part so he decided to implant fixed ps articular surface instead.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).G2: foreign - japan.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified a screw that was fractured and missing the threads.The device history record was reviewed and no discrepancies relevant to the reported event were found.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.

• Brand Name: 10MM HEIGHT SIZE E,F WITH LOCKING SCREW GREEN ARTICULAR SURFACE USE WITH FEMORAL
• 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: 17732660
• MDR Text Key: 323227383
• Report Number: 0001822565-2023-02495
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024635807
• UDI-Public: (01)00889024635807(17)270714(10)65539719
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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 Model Number: N/A
• Device Catalogue Number: 00599404010
• Device Lot Number: 65539719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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): Other