MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Embolism (1829); Patient Problem/Medical Problem (2688)

Event Date 07/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant associated products : item#:42502006402; femur cemented cruciate retaining (cr); lot#:64413839.Item#:42522100813; articular surface medial congruent (mc) ; lot#:64557921.Item#:42540000032; all poly patella cemented 32 mm diameter; lot#:64775213.Multiple mdr reports were filed for this event, please see associated reports: 3007963827 -2020 -00201, 0001822565-2020 -03006, 0002648920-2020-00383.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.If a 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.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 of dvt/pe, where medical intervention was completed to treat the pe.

Event Description

The patient was noted to have an acute pulmonary embolism on three days post-op, following a primary right unilateral total knee, requiring hospitalization and medical intervention.

• Brand Name: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE E
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10436926
• MDR Text Key: 203845489
• Report Number: 3007963827-2020-00200
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024471061
• UDI-Public: (01)00889024471061
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2020

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: 42532007102
• Device Lot Number: 64588474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• 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 Weight: 108