MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA STEMMED TIBIA; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Embolism (1829); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: persona femur cemented posterior stabilized (ps) standard catalog # 42500606402 lot # 63362725, persona articular surface fixed bearing posterior stabilized (ps) catalog # 42522400713 lot # 63029895, persona all poly patella catalog # 42540200035 lot # 63326893, 3.5mm hex head screw x38mm catalog # 20800000018 lot # unknown.The complainant has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Event was initially reported on 0001822565-2019-04978.Multiple mdr reports were filled for this event: 3007963827-2020-00040, 0001822565-2019-04979, 0001822565-2019-05075.Remains implanted.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was experienced a blood clot from the surgery.Attempt for further information has been made, but no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, 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.As the complaint indicated a post-operative complication developed and it can be implied medical intervention was required to treat the complication, therefore our complaint category, medical: procedure related would be appropriate.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.

• Brand Name: PERSONA STEMMED TIBIA
• 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: 9643265
• MDR Text Key: 177538538
• Report Number: 3007963827-2020-00039
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K122765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42532007102
• Device Lot Number: 63315961
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 83