MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR-FLEX PCT FEM G-R MINUS; PROSTHESIS, KNEE

Catalog Number 00595001706

Device Problems Material Erosion (1214); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)

Event Date 10/03/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: stemmed tibial component precoat size 6 for cemented use only: catalog#00598004702, lot#62380573; articular surface size green/c-h 14 mm height: catalog#00595204014, lot#ni.G2: foreign: australia.Multiple mdr reports have been filed for this event.Please see associated reports: 0002648920-2023-00256; 0001822565-2023-02958.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.

Event Description

It was reported that a patient underwent an initial right total knee arthroplasty.Subsequently, ten years and one month post-implantation, the patient was revised due to grinding noises in the joint while walking and poly fracture with metal-on-metal wear noted on x-ray.All components were exchanged without complication.Due diligence is in progress for this event; to date no further information has been reported.

Event Description

No further event information at time of this report.

Manufacturer Narrative

H6: proposed component code: mechanical (g04) - femur.Visual examination of the provided pictures identified that all the implants show signs of use as foreign materials coat the surfaces of the implants.The femoral mating surface shows wear marks.As the implant was not returned further evaluations could not be performed.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial surgical report: components cemented and stable on testing; no intraop complications noted.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: overall fit is appropriate.Medial compartment polyethylene wear with possible fracture of the polyethylene implant.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Reported event was confirmed by review of provided pictures.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.

• Brand Name: CR-FLEX PCT FEM G-R MINUS
• 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: 18015951
• MDR Text Key: 326651429
• Report Number: 0001822565-2023-02959
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K023211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00595001706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 90 KG