MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED POSTERIOR STABILIZED (PS); PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: persona stemmed tibia catalog # 42532006701 lot # 65071773.Persona articular surface fixed bearing constrained posterior stabilized (cps) catalog # 42512600512 lot # 64127652.Persona all poly patella catalog # 42540000032 lot # 65134407.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 3007963827-2021-00317, 3007963827-2021-00318, 0002648920-2021-00444.Device evaluated by manufacturer? remains implanted.
Event or Problem Description
It was reported patient developed a pulmonary embolism four days post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It was reported that a morbidly obese patient (bmi > 64) experienced a pulmonary embolism 4 days postop.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.After the total knee arthroplasty, the patient was placed on eliquis for dvt/pe prophylaxis.The patient reported missing a dose of eliquis during treatment.The patient was seen in the emergency department with bilateral pes identified.The patient's dose of eliquis was increased, and the patient was discharged without hospital admission and without further 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 POSTERIOR STABILIZED (PS)
• Common Device Name: 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: 12960402
• Report Number: 3007963827-2021-00316
• Device Sequence Number: 19270338
• Product Code: JWH
• UDI-Device Identifier: 00889024228771
• UDI-Public: (01)00889024228771(17)310524(10)65045294
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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: 42500006401
• Device Lot Number: 65045294
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 122 KG