MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CRUCIATE RETAINING RIGHT SIZE 11 PPS NARROW FEMUR; PROSTHESIS, KNEE

Model Number N/A

Device Problems Difficult to Insert (1316); Malposition of Device (2616)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a knee procedure, a press fit femur did not seat as the surgeon wanted.He elected to use a cemented femoral instead.

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.Suggested component code: mechanical (04) - femur.Complaint sample was evaluated and the reported event could not be confirmed.Visual examination of the returned product found there is damage on both femoral condyles (scuffs, gouges) consistent with an attempt at checking the fit.Also performed dimensional analysis on the post diameter and general reference of the distance between them center to center, all dimensions within specifications.Device history record was reviewed and no discrepancies were found.A root cause could not be determined as the issue was not confirmed.A summary of the investigation has been sent to the complainant.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: CRUCIATE RETAINING RIGHT SIZE 11 PPS NARROW FEMUR
• 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: 18425305
• MDR Text Key: 331875857
• Report Number: 0001822565-2023-03834
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024631205
• UDI-Public: (01)00889024631205(17)330604(10)65942926
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 42508007002
• Device Lot Number: 65942926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• 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 Sex: Male