MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 38 MM DIAMETER; 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	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi # (b)(4).Concomitant medical products: item#:42502607001; femur cemented cruciate retaining (cr) lot#:64284731, item#:42532007501; tibia cemented 5 degree stemmed left size f lot#:64154924, item#:42512100810; articular surface medial congruent (mc) lot#:64163685.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 adminstration 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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00077, 3007963827-2020-00078, 3007963827-2020-00079.Remains implanted.
Event or Problem Description
It was reported that a study patient had an initial left total knee arthroplasty and was diagnosed with a right lower extremity dvt less than 3 months post-op.Medical intervention occurred, and the outcome has been noted as resolved.

• Brand Name: ALL POLY PATELLA CEMENTED 38 MM DIAMETER
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9829643
• Report Number: 0002648920-2020-00173
• Device Sequence Number: 740398
• Product Code: MBH
• UDI-Device Identifier: 00889024247659
• UDI-Public: (01)00889024247659
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 42540000038
• Device Lot Number: 64333024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/13/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 117