MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT PRECOAT SIZE E RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism (1829)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00345 and 3007963827-2020-00174.Concomitant medical devices: all poly patella standard size 32 mm diameter 8.5 mm thickness catalog#: 00597206532 lot#: 64591619, trabecular metal cruciate retaining monoblock tibial component: yellow size 4 c-h 10mm catalog#: 00588604410 lot#: 64059750.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient developed right deep vein thrombosis approximately two weeks after right total knee arthroplasty.No additional patient consequences were reported.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, b7, g4, g7, h2, h3, h6, and h10.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.Root cause can be attributed to the procedure.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL COMPONENT PRECOAT SIZE E RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 10255909
• Report Number: 3007963827-2020-00174
• Device Sequence Number: 19704297
• Product Code: JWH
• UDI-Device Identifier: 00889024206984
• UDI-Public: (01)00889024206984(17)290731(10)64247000
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 00595001502
• Device Lot Number: 64247000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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 Weight: 61