MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET FINNED PRI STEM; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Syncope (1610); Fall (1848)

Event Date 01/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vanguard cr ilok fem-rt catalog # 183006 lot # 6494487, vngd ant stab brg catalog # 189061 lot # 959300, series a pat std catalog # 184764 lot # 069360.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.Multiple mdr reports were filled for this event: 0001825034-2020-00471, 0001825034-2020-00473, 0001825034-2020-00474.Remains implanted.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient experienced a syncopal episode at home which resulted in a laceration to the nasal bridge of nose.

Event Description

From additional information, it was further reported that the patient was prescribed physical therapy approximately one month after surgery for weakness and difficulty with ambulating.

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.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Anesthesia administration has common side effects which can cause a syncopal episode.Syncope is defined as a temporary decrease in the amount of blood that flows to the brain in which the patients body will perceive as fainting or passing out.Syncopal episodes are typically caused by a sudden drop in blood pressure, heart rate or decreased volume which can occur post op from medication, changing positions too quickly and/or holding their breath.Anesthetic medication typically takes the average healthy patient 24 hours post administration to fully metabolize.As this specific patient was discharged the same day of surgery, the event can be related to the unmetabolized anesthetic medications provided intra and post op.As the complaint indicated the patient developed a post-operative complication requiring medical treatment, the 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.

Event Description

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

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

From additional information, it was reported that the patient not only had a syncopal episode, but also fell.Further, it was reported that the patient was taking pain medications.Finally, the patient was referred to a plastic surgeon for repair and the laceration was corrected with sutures.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: BIOMET FINNED PRI STEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9675820
• MDR Text Key: 177944608
• Report Number: 0001825034-2020-00472
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K915132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• 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: 141314
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 70