MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL KNEE HIGH FLEX PRECOAT CEMENTED FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Flaked (1246)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant devices - zimmer unicompartmental knee precoat tibial component left catalog #: 00584200301 lot #: 62458157, unknown zimmer unicompartmental knee articular surface catalog #: ni lot #: ni.Report source - foreign: (b)(6).Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2022-00756 and 0001822565-2022-00758.

Event Description

It was reported that the patient underwent a knee arthroplasty revision to address pain approximately eight (8) years post-operatively.During the removal of the implants, it was identified that the coating of the metallic implants was peeling.Attempts have been made, however, no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10 - concomitant devices - zimmer unicompartmental knee precoat tibial component left catalog #: 00584200301 lot #: 62458157, zimmer unicompartmental knee articular surface size 3 10mm catalog #: 00584202310 lot #: 62205764 h6 - component code - proposed code is mechanical (g04) - femur.Visual examination of pictures provided identified remains of cement on the femoral component.The articular surface exhibited signs of being implanted as well as wear on the surface.The tibial tray had no evidence of cement and scrape marks were found on the device.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed component (annex g) code is mechanical (g04) - femur.Visual examination of the provided implant found sign of being in-vivo with some scratches to femur and tibial plate and wear on the articular surface.These scratches in femur and tibial components likely happen during explanation.No bone cement can be seen on both femur and tibial plate.The root cause remains unchanged.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: ZIMMER UNICOMPARTMENTAL KNEE HIGH FLEX PRECOAT CEMENTED FEMORAL COMPONENT
• 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: 13823063
• MDR Text Key: 289513744
• Report Number: 0001822565-2022-00757
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033363
• 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,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00584201401
• Device Lot Number: 62518017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2013
• 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): Required Intervention; Hospitalization
• Patient Sex: Female