MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Wound Dehiscence (1154)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical products: persona femur cemented retaining (cr) standard catalog # 42502606602 lot # 64710079.Persona articular surface medial congruent (mc) catalog # 42522100813 lot # 64645122.Persona all poly patella catalog # 42540000038 lot # 64621053.Customer has indicated that the product will not be returned because it remains implanted.It was reported the patient developed a non healing area at the proximal end of the surgical incision with mild swelling, redness and drainage.Patient was given oral antibiotics as a preventive measure and aspiration was performed with no indication of infection.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression wound concerns or non-healing wound would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process.Aspiration can be defined as the withdrawal of fluid from a cavity and the purpose of aspiration is to remove fluid or air from an affected area or to obtain specimens (tabers medical dictionary).Aspiration is typically done in a joint for diagnostic purposes.Multiple mdr reports were filled for this event: 3007963827-2020-00278.3007963827-2020-00279.0002648920-2020-00473.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient experienced a wound complication requiring medical intervention.The patient's incision widened at the proximal aspect of the wound (3/4cm w x 3cm l) with minimal drainage.An aspiration was performed and 10ml was obtained and patient was prescribed antibiotics.No revision procedure has been reported to date.Attempt for further information has been made, but no further information has been provided.

• Brand Name: PERSONA NATURAL TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10727230
• MDR Text Key: 212768865
• Report Number: 0001822565-2020-03632
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

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: 42530007502
• Device Lot Number: 63905758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 89