MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); Pain (1994); Swelling (2091)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2020-00213, 3007963827-2020-00214, and 0002648920-2020-00394.Medical devices: femur cemented posterior stabilized (ps) narrow right size 8 catalog#: 42500006402 lot#: 64441570, tibia cemented 5 degree stemmed right size d catalog#: 42532006702 lot#: 64318875, all poly patella cemented 29 mm diameter catalog#: 42540000029 lot#: 64620917.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 Description

It was reported that the patient had a deep vein thrombosis approximately one week after right knee arthroplasty.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 of dvt developed and it can be implied medical intervention was required to treat the complication, therefore our complaint category, medical: procedure related would be appropriate.

Event Description

It was reported that the patient had a deep vein thrombosis approximately one week after right knee arthroplasty.The patient was prescribed an anticoagulant and remained on it for approximately 3 months with no further mention of deep vein thrombosis.

• Brand Name: ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 11 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 10482252
• MDR Text Key: 205284194
• Report Number: 3007963827-2020-00215
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42522400511
• Device Lot Number: 64405629
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 64