MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT, LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); Swelling (2091); Reaction (2414)

Event Date 12/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) concomitant medical products: 00542801009, bearing, 61136943.00542000800, patella, 61621399.642000100, tibial tray, 61493582.The articular surface was returned for further analysis.The articular surface fractured on the medial side.Burnishing and abrasion were identified on the lateral side.Sem analysis demonstrated that damage observed is consistent with typical in vivo use, from explantation damage, and of potential overloading.The dhr was reviewed and no discrepancies relevant to the reported event were found.Initial op notes demonstrated that the patient had left tka due to osteoarthritis.Revision op notes demonstrated that the patient was revised due to articular surface fracture, and metal wear debris synovitis and effusion.The patient experienced instability, catching, swelling, and stiffness.The diagnosis was again pes anserinus and the patient had an injection.Patient is allergic to nickel.No infection was found upon aspiration.Wear was noted through the poly.There was a fracture in the poly posteromedially and that there was scratching of the metal femoral component over the medial femoral condyle.There were 3 cysts noted around the tibial plateau.Bone cement was identified on the tibial and femoral components.Minor scratches were identified in the lateral side and more were identified on the medial side of the femoral component.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01540, 0001822565 - 2019 - 01544.

Event Description

It was reported that the patient underwent left knee revision approximately 5 years post implantation due to pain, swelling, stiffness, instability, ligament laxity, and poly wear and fracture.The patient is also allergic to nickel.

• Brand Name: GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT, LEFT
• 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: 9963060
• MDR Text Key: 193264781
• Report Number: 0001822565-2019-01543
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00541401401
• Device Lot Number: 61789863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2011
• 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
• Patient Weight: 77