MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TRABECULAR METAL 2-PEG POROUS FXD BRG RT SIZE E; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Erosion (1750); Hematoma (1884); Pain (1994)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 42502206402 persona femur trabecular metal (cr) narrow porous lot# 64278729.42522100810 persona articular surface medial congruent (mc) right 10 mm lot# 64375813.

Event Description

It was reported a patient had an initial right total knee arthroplasty followed by a manipulation under anesthesia one month later.Subsequently, patient began to have pain and swelling one month post mua, and an i&d was performed on an infected extra-articular hematoma.A subsequent i&d due to ongoing extra-articular infection was performed another month after the previous i&.The two i&ds failed to resolve the infection and a two stage revision was performed about one month post procedure.During the revision, medially encountered purulence with positive cultures of staphylococcus aureus and erosion was noted through the external fascia.All implants, except the patella, were removed and a new femoral component was implanted with a spacer.Eleven moths after placing the spacer a stage ii revision was completed without complication and a new revision system was implanted.

• Brand Name: PERSONA TIBIA TRABECULAR METAL 2-PEG POROUS FXD BRG RT SIZE E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19133136
• MDR Text Key: 340478218
• Report Number: 0001822565-2024-01299
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024510562
• UDI-Public: (01)00889024510562(17)290430(10)64077537
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2024

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: 42530007102
• Device Lot Number: 64077537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White