MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Difficult to Insert (1316); Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: japan.Customer 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.

Event Description

It was reported the patient underwent a total knee arthroplasty.During the procedure, the surgeon had difficulty seating the tibial insert in the tibial tray.After seating it in the tibial tray, the surgeon removed the insert from the tibial tray and noted the backside of the tibial insert peeled off.The surgeon attempted to seat the tibial insert again but the same issue occurred.The surgery was completed with a different tibial insert.No adverse events have been reported as a result of the malfunction.

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.Reported event was confirmed by review of photograph.Visual examination of the provided pictures shows only white poly string which looks like separated from the articular surface.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.The root cause of the reported issue is attributed to user error because surgeon was hitting the articular surface during the insertion.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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: ARTICULAR SURFACE MEDIAL CONGRUENT (MC) LEFT 12 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15599176
• MDR Text Key: 306153383
• Report Number: 3007963827-2022-00258
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024469310
• UDI-Public: (01)00889024469310(17)261026(10)65197609
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150090
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42512100812
• Device Lot Number: 65197609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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