MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA FEMUR CEMENTED CRUCIATE RETAINING (CR); PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Embolism/Embolus (4438); Swelling/ Edema (4577)
Date of Event	09/11/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona stemmed 5-degree tibia catalog # 42532006702 lot # 64965172.Persona articular surface fixed bearing cruciate retaining (cr) catalog # 42522000413 lot # 64425864.Persona all poly patella catalog # 42540000032 lot # 65061482.Unknown cement catalog # unknown lot # unknown.Multiple mdr reports were filled for this event: 3007963827-2022-00023, 3007963827-2022-00024, 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 FEMUR CEMENTED CRUCIATE RETAINING (CR)
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13315488
• Report Number: 0001822565-2022-00136
• Device Sequence Number: 11927933
• Product Code: JWH
• UDI-Device Identifier: 00889024575974
• UDI-Public: (01)00889024575974(17)310608(10)65123720
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K193223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42572006002
• Device Lot Number: 65123720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White