MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Pulmonary Embolism (1498)

Event Date 07/11/2022

Event Type  Injury  

Event Description

It was reported via study that the patient developed a pulmonary embolism requiring hospitalization approximately forty (40) days post implantation.No further interventions have been reported.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00211, 3007963827-2022-00213, and 0002648920-2022-00177.Medical devices: femur cemented cruciate retaining (cr) narrow left size 7 catalog#: 42502006201 lot#: 65069289; tibia cemented 5 degree stemmed left size d catalog#: 42532006701 lot#: 65329302; all poly patella cemented 29 mm diameter catalog#: 42540000029 lot#: 65346185.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.If a deep vein thrombosis (dvt)/ blood clot breaks free, it may travel through the bloodstream and block blood flow to the lungs.This complication is called a pulmonary embolism (pe).Total joint patients are typically placed on medication post-operative for a period of time to help prevent the development of dvt/blood clot formation that can lead to an pe.As the complaint indicated, the patient developed a post-operative complication, and medical intervention was completed to treat the pe.

Event Description

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

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15244618
• MDR Text Key: 298109769
• Report Number: 3007963827-2022-00212
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024468993
• UDI-Public: (01)00889024468993(17)261207(10)65334146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• 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: 42512100412
• Device Lot Number: 65334146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• 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; Other
• Patient Sex: Female
• Patient Weight: 77 KG