MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA POROUS TRABECULAR METAL STANDARD FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).G2 - report source - foreign: the event occurred in singapore.The 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 during knee arthroplasty when the surgeon went to open the cementless femoral component, the packaging appeared dented, and the inner sterile packaging already partially opened.Due to the sterile barrier being compromised, the surgeon had to utilize a cemented femoral component to complete the procedure instead.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.Visual evaluation of the returned device identified that the inner and outer sterile blisters exhibited damage visually consistent with thermal damage.Further evaluation identified that the tyvek had lifted in multiple areas on both blisters.Sterility was confirmed to have been breached.The device history records were reviewed and no discrepancies were identified.The condition of the device when it left zimmer biomet was considered non-conforming to specification and therefore the root cause of the reported event is attributed to the packaging operator not following the work instructions provided.Corrective actions have been initiated to address the 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.

Event Description

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

• Brand Name: PERSONA POROUS TRABECULAR METAL STANDARD 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: 17423549
• MDR Text Key: 320025710
• Report Number: 0001822565-2023-02006
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024230798
• UDI-Public: (01)00889024230798(17)330407(10)65792918
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K172524
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: 42502806601
• Device Lot Number: 65792918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2023
• 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: Prefer Not To Disclose