MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR); PROSTHESIS KNEE

Model Number N/A

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

Patient Problems Pain (1994); Embolism/Embolus (4438); Swelling/ Edema (4577)

Event Date 09/11/2021

Event Type  Injury  

Event Description

It was reported patient is experiencing pain, swelling and deep vein thrombosis fifteen days post implantation and required medication to alleviate the symptoms.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).Medical products: persona femur cemented cruciate retaining (cr) catalog # 42572006002 lot # 65123720.Persona stemmed 5-degree tibia catalog # 42532006702 lot # 64965172.Persona all poly patella catalog # 42540000032 lot # 65061482.Unknown cement catalog # unknown lot # unknown.Multiple mdr reports were filled for this event: 0001822565-2022-00136, 3007963827-2022-00023, 0002648920-2022-00012.It was reported a patient experienced a dvt approximately 2 weeks postop.The patient was placed on stronger anticoagulants, and the dvt resolved without further complication by the next follow up the following week.Procedural related complications are influenced by the type of surgery, patients pre existing comorbid state, and perioperative management.Deep vein thrombosis, or dvt, occurs when a blood clot forms in one of the deep veins of the body.This can happen if a vein becomes damaged or if the blood flow within a vein slows down or stops.Total joint patients are typically placed on medication post-operative for a period of time to prevent the development of dvt/blood clot.Even with the administration of preventive medication, dvt/blood clots can still develop.As the complaint indicated a post-operative complication developed and it can be implied medical intervention was required to treat the complication.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR)
• 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: 13315511
• MDR Text Key: 284190887
• Report Number: 3007963827-2022-00024
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024241589
• UDI-Public: (01)00889024241589(17)250131(10)64425864
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• 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
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• 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: 42522000413
• Device Lot Number: 64425864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2020
• 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): Other
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White