MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RIGHT SIZE G CEMENTED OPTION FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2: foreign - france.The 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 that during an initial surgery, when definitive implants were taken, the medical staff opened the outer packaging for the lcck right femoral implant size g.The outer cardboard packaging was intact, however, the two rigid plastic packs inside were broken, split in two.As a result, the implant could not be used because it was impossible to guarantee its sterility.There was a 90 minute surgical delay while a new implant was obtained from another hospital.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: visual evaluation of the provided photos and returned product found the damage to both blisters is visually consistent with transit damage for this packaging configuration.Sterility has been breached.The device history record was reviewed and no discrepancies relevant to the reported event were found.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage.This complaint was confirmed by evaluation of the provided photos and returned product.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.

Event Description

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

• Brand Name: RIGHT SIZE G CEMENTED OPTION FEMORAL COMPONENT
• 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: 18257605
• MDR Text Key: 329618466
• Report Number: 0001822565-2023-03439
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024224858
• UDI-Public: (01)00889024224858(17)290228(10)64291378
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173057
• 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: 03/13/2024

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: 00599401792
• Device Lot Number: 64291378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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
• Patient Weight: 76 KG