MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 15MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION COMBINED LENGTH 145MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: foreign - france.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02280, 0001822565-2023-02281, 0001822565-2023-02282.

Event Description

It was reported that the patient underwent a revision of the rotating hinged knee prosthesis in a septic context.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial right total knee arthroplasty on an unknown date.Subsequently, the patient was revised due to chronic infection.All components were revised without complications.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Part of the product was returned.However, testing was not done as visual examination is insufficient for the reported event of infection.The device history record was reviewed and no discrepancies relevant to the reported event were found.Additionally, the sterile certificate was reviewed and noted to be conforming.It was sterilized in accordance with fda regulations and iso standards.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: chronic right tka infection, multiple samples taken for bacteriological analysis, synovectomy extended with removal of two att screws, good range of motion.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: 15MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION COMBINED LENGTH 145MM
• 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: 17615117
• MDR Text Key: 321871118
• Report Number: 0001822565-2023-02283
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024220997
• UDI-Public: (01)00889024220997(17)300802(10)64831370
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598801015
• Device Lot Number: 64831370
• 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: 08/08/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/20/2023; 12/07/2023
• Supplement Dates FDA Received: 10/10/2023; 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2020
• 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: Male
• Patient Weight: 90 KG