MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS FLEX SYSTEM ARTICULAR SURFACE CONGRUENT; PROSTHESIS KNEE

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products - gender solutions female (gsf) sinterlock porous coated femoral component # 00541601502 lot # 62705770.Gender solutions tibial tray #630701220 lot # 62711317.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-07868.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted in the patient body.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient is experiencing pain and the knee pops when she bends and walks.She is currently using a cane to walk and the knee is tender to touch.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Per package insert, pain, dislocation and joint instability is one of the known adverse effects of the tka procedure.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

It was reported that the patient is experiencing pain, and the knee pops upon bending and pops out of place while walking.Patient uses a cane to walk and the knee is tender to touch.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: GENDER SOLUTIONS FLEX SYSTEM ARTICULAR SURFACE CONGRUENT
• 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: 7039056
• MDR Text Key: 92277876
• Report Number: 0001822565-2017-07869
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070214
• 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,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00542402111
• Device Lot Number: 62432637
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2013
• 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: 118