MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/27/2023

Event Type  Injury  

Event Description

It was reported the patient underwent a knee procedure on an unknown date.Subsequently, the patient was revised due to tibial subsidence.Surgeon is of the opinion the subsidence may be due to possible patient poor bone quality rather than implant failure.

Manufacturer Narrative

(b)(4).G2: new zealand.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products: 42558000302, partial femur cemented, size 3, right lot# 64967237.42528200508, partial articular surface right medial, size e, 8mm lot# 64660632.66022663, palacos r+g 1x40, lot# 60771089.Not zimmerbiomet distributed product.

Event Description

It was reported the patient underwent a knee procedure.Subsequently, approximately 5 months post procedure, the patient was revised due to tibial subsidence.Surgeon is of the opinion the subsidence may be due to possible patient poor bone quality rather than implant failure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.This complaint could not be confirmed.The surgeon believes the subsidence was due to poor bone quality, however this cannot be confirmed.Therefore, a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE E RIGHT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16775749
• MDR Text Key: 314094746
• Report Number: 0001825034-2023-00829
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812697
• UDI-Public: (01)00880304812697(17)271130(10)63867312
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000502
• Device Lot Number: 63867312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• 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