MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA FEMORAL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Event Description

It was reported a journal article was retrieved from journal of orthopaedics, trauma and rehabilitation (2022) that reported a retrospective study from egypt that focused on the incidence of periprosthetic fractures after total knee arthroplasty (tka) in obese asian patients.The purpose of the study was to compare the incidence of early postoperative periprosthetic fractures in the cruciate retaining (cr) and posterior stabilized (ps) knee prosthesis.The study reviewed 352 patients with 600 primary tkas (300 cases of cruciate retaining tkas from 178 patients and 300 cases of posterior stabilized tkas from 174 patients).All tkas were performed by a single surgeon from january 2014 and may 2018 using the zimmer persona system.The study population had a mean age of 72.4 years at time of surgery (range 64-83).Of the 11 patients further followed due to periprosthetic fractures, 9 were female, 2 were male, and the average bmi was 37 (range, 32-43).Patient outcomes and radiology results were retrospectively reviewed; therefore, follow-up information was not included in the article.The study reported 4 patients developed insufficiency lateral femoral condyle periprosthetic fractures with no known history of trauma.One of these patients required a distal femoral replacement secondary to significant femoral bone loss.

Manufacturer Narrative

(b)(4).Report source foreign source: egypt.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Journal article reference: elkabbani et al.(2022) posterior stabilized total knee arthroplasty increases the risk of postoperative.Periprosthetic fractures.Journal of orthopaedics, trauma and rehabilitation, volume 29, 1-8.Doi: 10.1177/22104917221082317.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- femur.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: UNKNOWN PERSONA FEMORAL
• 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: 16020263
• MDR Text Key: 305874222
• Report Number: 0001822565-2022-03524
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention