MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent an initial right total knee arthroplasty.It was reported that the patient developed a deep vein thrombosis approximately 3 days post implantation.The patient was treated medically and issue resolved, with components remaining implanted.No further information is available.
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Articular surface medial congruent (mc) right 11 mm height use with tibia sizes g-h/cr femur sizes 8-11.Concomitant medical products: 42502807002, femur trabecular metal cruciate retaining (cr) standard porous, lot 64816910, 42530007902, natural tibia trabecular metal two-peg porous fixed bearing right size g, lot 64883676, 42540000035, all poly patella cemented 35 mm diameter, lot 64833127, 110035368, biomet bc r 1x40 us, lot e2704z12aa.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00602, 0001822565-2022-00603 and 0002648920-2022-00045.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.It was reported a patient underwent a total knee arthroplasty, and subsequently, developed a dvt three days post-operatively.The dvt was resolved without complications.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 medical intervention was required to treat the complication.Review of device history records was not performed as the root cause of the event is non-device related.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.
Event or Problem Description
No additional information.

• Brand Name: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 11 MM
• 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: 13595355
• Report Number: 3007963827-2022-00058
• Device Sequence Number: 1931065
• Product Code: MBH
• UDI-Device Identifier: 00889024468504
• UDI-Public: (01)00889024468504(17)250908(10)64880971
• 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): 06/14/2022

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: 09/08/2025
• Device Model Number: N/A
• Device Catalogue Number: 42522100911
• Device Lot Number: 64880971
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White