MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM HEIGHT; 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); Thrombosis/Thrombus (4440)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant products: 42502006401 - femur cemented cruciate retaining (cr) narrow left size 8 - 64623544; 42532007101 - natural tibia cemented 5 degree stemmed left size e - 65020611; 42540000035 - all poly patella cemented 35 mm diameter - 65134465; 0752110034355 - refobacin bc r 1x40 us - z46aaj2605.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports 3007963827-2021-00306, 3007963827-2021-00307, 0002648920-2021-00424.
Event or Problem Description
It was reported that the patient had an initial left total knee arthroplasty.On the day of surgery, a deep vein thrombosis was identified on imaging.The patient was placed on a stronger anticoagulant and different medications for severe pain.Attempts have been made and no further information has been provided.
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 dvt was identified on imaging on the day of surgery after a total knee arthroplasty.The patient also had a recent dvt due to covid.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 11 MM HEIGHT
• 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: 12883825
• Report Number: 3007963827-2021-00308
• Device Sequence Number: 4982154
• Product Code: MBH
• UDI-Device Identifier: 00889024469303
• UDI-Public: (01)00889024469303(17)260615(10)65063016
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• 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): 03/15/2022

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 Expiration Date: 06/15/2026
• Device Model Number: N/A
• Device Catalogue Number: 42512100811
• Device Lot Number: 65063016
• 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: 11/12/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White